Arc Staghorn Calculi

American Urological Association, Inc.
Nephrolithiasis Clinical Guidelines Panel:
Report on the Management of Staghorn Calculi
Archived Document For Reference Only
Clinical Practice Guidelines
Nephrolithiasis Clinical Guidelines Panel Members and Consultants

Joseph W. Segura, M.D., Chairman The Carl Rosen Professor of Urology Department of Urology The Mayo Clinic Rochester, Minnesota Dean G. Assimos, M.D. Assoc. Professor of Surgical Sciences Department of Urology The Bowman Gray School of Medicine Wake Forest University Winston-Salem, North Carolina Stephen P. Dretler, M.D. Director, Kidney Stone Center Massachusetts General Hospital Boston, Massachusetts Robert I. Kahn, M.D. Chief of Endourology California Pacific Medical Center San Francisco, California James E. Lingeman, M.D. Director of Research Methodist Hospital Institute for Kidney Stone Disease Associate Clinical Instructor in Urology Indiana University School of Medicine Indianapolis, Indiana Glenn M. Preminger, M.D., Facilitator Professor, Department of Urology Duke University Medical Center Durham, North Carolina Joseph N. Macaluso, Jr., M.D. Medical Dir.; Dir. of Grants & Research Urologic Institute of New Orleans Assoc. Professor & Dir. of Endourology, Lithotripsy & Stone Disease Louisiana State Univ. Medical Center School of Medicine New Orleans, Louisiana David L. McCullough, M.D. William H. Boyce Professor Chairman, Department of Urology The Bowman Gray School of Medicine Wake Forest University Winston-Salem, North Carolina Claus G. Roehrborn, M.D. Facilitator Coordinator Hanan Bell, Ph.D. Methodology and Statistical Consultant Curtis Colby Editor Patrick Florer Computer Database Design Consultant
The Nephrolithiasis Clinical Guidelines Panel consists of board-certified urologists who are experts in stone disease. This Report on the Management of Staghorn Calculi was extensively reviewed by over 50 urologists throughout the country in the Fall of 1993. The Panel finalized its recommendations to AUAs Practice Parameters, Guidelines and Standards Committee, Chaired by Winston K. Mebust, MD, in December 1993. The AUA Board of Directors approved these practice guidelines at its meeting in January 1994. The Summary Report also underwent independent scrutiny by the Editorial Board of the Journal of Urology, was accepted for publication in March 1994, and appeared in its June issue. A guide to assist patients diagnosed with this condition has also been developed. The Technical Supplement to this Report is available upon request. The American Urological Association expresses its gratitude for the dedication and leadership demonstrated by the members of the Nephrolithiasis Clinical Guidelines Panel in producing the AUAs first explicit guideline using the Eddy methodology.
Introduction
Urologists and patients can choose from many alternatives today for management of renal and ureteral calculi. The improvements in urologic equipment, radiologic technology, and interventional radiologic techniques have dramatically increased the means available for stone removal. As a consequence, however, questions have arisen regarding applications of particular modalities to treat the various types of stone disease. To help clarify treatment issues, the American Urological Association, Inc., convened the Nephrolithiasis Clinical Guidelines Panel in 1990 and charged it with the task of producing practice recommendations based on outcomes evidence from the treatment literature.
Archived Document The recommendations in this Report on the Management of For Reference Only Staghorn Calculi are to assist physicians in the treatment specifically of struvite staghorn calculi. Although relatively uncommon, these kidney stones present serious problems because they occur in the presence of urinary tract infections and because the stones themselves are infected. Treatment must remove stones completely to eradicate all infected stone material. The choice of treatment can be a source of controversy given the range of modalities and techniques now available, each with advantages and disadvantages. This makes struvite staghorn calculi an especially appropriate subject for evidence-based recommendations.
A Patients Guide and more detailed technical appendices are available upon request.
Contents
Executive Summary: Treatment of staghorn calculi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Methodology for development of treatment recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Background: Staghorn calculi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Treatment outcomes and alternative modalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Treatment recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Limitations in the treatment literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Chapter 1: Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Literature search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Article selection and data extraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Evidence combination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Chapter 2: Staghorn calculi and their management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Treatment Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Chapter 3: Outcomes analysis for staghorn treatment alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Direct and indirect outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Combining outcome evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 The balance sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Analysis of the balance sheet outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Chapter 4: Staghorn treatment recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Treatment outcomes and treatment recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 The patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Recommendations: Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Recommendations: Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Recommendations: Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Recommendation limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Basic research needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 Appendix A: Data presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A.1 Appendix B: Data abstraction worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B.1 Appendix C: Description of available techniques for management of renal and ureteral calculi . . . . . . . . . . . .C.1 Shock-wave lithotripsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.1 Percutaneous nephrolithotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.3 Ureteroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.4 Open lithotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.5 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .I.1
Production and layout by Lisa Emmons Tracy Kiely Betty Roberts Copyright 1994 American Urological Association, Inc.
Executive Summary: Treatment of staghorn calculi

METHODOLOGY
FOR DEVELOPMENT OF TREATMENT RECOMMENDATIONS
In developing recommendations for managing staghorn calculi, the AUA Nephrolithiasis Clinical Guidelines Panel reviewed the available literature on treatment of struvite staghorn calculi. Relevant articles were selected for data extraction, and the panel devised a comprehensive data-extraction form to capture as much pertinent information as possible. Data analysis was conducted using the confidence profile method developed by Eddy and Hasselblad [Eddy, 1989; Eddy, Hasselblad, and Shachter, 1990]. Chapter 1, Methodology, provides a full description of the process.
BACKGROUND: STAGHORN
Staghorn calculi are stones that fill the major part of the collecting system. Typically, such stones will occupy the renal pelvis, and branches of the stone will extend into the majority of the calices. The term partial staghorn is often used when a lesser portion of the collecting system is occupied by stone. There is, unfortunately, no agreement on how these terms should be defined, and the term staghorn is often used irrespective of the percentage of the collecting system occupied. There is also no widely accepted way to express the size of a staghorn calculus. As a result, stones of widely different volumes are all referred to as staghorns. Staghorn calculi are usually made of struvite (magnesium ammonium phosphate) with variable amounts of calcium, but stones made of cystine, calcium oxalate monohydrate, and uric acid can all fill the collecting system. Such stones are frequently found intermixed with struvite calculi in many series reported in the literature. The majority of staghorn stones are composed of struvite. These stones tend to be soft, and their radiologic appearance varies from relatively faint to moderately radiopaque. It is generally possible to predict on the basis of a plain x-ray film that a staghorn stone is composed of struvite.

CALCULI
These stones are also called infected stones or infection stones because they occur only in the presence of urinary tract infection and only when the infection is secondary to organisms that elaborate the enzyme urease, which splits urea [Bruce and Griffith, 1981]. Cultures of pieces of struvite stones, taken both from the surface and from inside, have demonstrated that bacteria reside inside the stones and that the stones themselves are infected in contrast to stones made of cystine, calcium oxalate monohydrate, or other substances [Nemoy and Stamey, 1971]. An untreated struvite staghorn calculus will in time destroy the kidney, and the stone has a significant chance of causing the death of the affected patient [Rous and Turner, 1977; Koga, Arakai, Matsuoka, et al., 1991]. Moreover, struvite stones must be removed in their entirety to be certain of eradicating all of the infected stone material. If all of the infected material is not removed, the patient will continue to have recurrent urinary tract infections and the stone will eventually regrow. It may be possible to sterilize small amounts of struvite, but how much of the stone can be sterilized is uncertain and unpredictable [Pode, Lenkovsky, Shapiro, et al., 1988; Michaels and Fowler, 1991]. The panel found four modalities reported in the literature to be potential alternatives, on the strength of the evidence, for treating patients with struvite staghorn calculi: Open surgery referring to any method of open surgical exposure of the kidney and removal of stones from the collecting system; Percutaneous nephrolithotomy (PNL); Extracorporeal shock-wave lithotripsy (SWL); and Combinations of PNL and SWL. Because the panel was unable to conduct direct assessments of patient preferences, panel members themselves acted as patient surrogates judging treatment choices on the basis of probable outcomes.
TREATMENT
OUTCOMES AND ALTERNATIVE MODALITIES
After reviewing the literature and analyzing the data, the panel concluded that the following outcome probabilities are the most significant in setting forth recommendations for treatment of struvite staghorn calculi: The probability of being stone free following treatment; The probability of undergoing secondary, unplanned procedures; and The probability of having complications associated with the chosen primary treatment modality. The four modalities of open surgery, PNL, SWL, and combination PNL and SWL are all reasonable treatment alternatives for patients with struvite staghorn calculi. However, outcome probabilities differ markedly among the four. The following statements are based on both statistical analysis of abstracted data from the treatment literature and expert opinion. They form the basis of the panels recommendations. The risk of having residual fragments following initial treatment is clearly higher after shock-wave lithotripsy monotherapy than after percutaneous nephrolithotomy, combination therapy, or open surgery. It is the expert opinion of the panel that residual fragments of infected calculi left in the renal collecting system may be associated with recurrent infections and eventual regrowth of these fragments into significant stones leading to additional morbidity, although literature to support this opinion is scarce. Shock-wave lithotripsy monotherapy carries a high probability of unplanned secondary procedures. Percutaneous nephrolithotomy, combination therapy, and open surgery are more likely to require general or regional anesthesia. The chance that a blood transfusion will be required is greater for percutaneous nephrolithotomy, combination therapy, and open surgery than for shock-wave lithotripsy monotherapy. Rates of complications following the four treatment modalities differ significantly for each modality. From the patients viewpoint, a complication may have the same importance as a secondary, unplanned procedure, inasmuch as it may require a second anesthetic procedure or prolong the
Archived Document T For Reference Only
patients hospital stay. Therefore, an analysis combining secondary, unplanned procedures and the complications associated with the primary treatment modalities chosen may accurately reflect the patients viewpoint regarding desirability or undesirability of a given intervention. Of all four treatment modalities, shock-wave lithotripsy monotherapy has the highest combined complication and secondary, unplanned intervention rate. However, the complications associated with shock-wave lithotripsy tend to be less severe than those associated with percutaneous nephrolithotomy, combination therapy, or open surgery. The peer-reviewed literature does not stratify outcomes appropriately by either size or composition of staghorn calculi or the anatomy of the collecting system. Nevertheless, the panel believes that these factors impact the outcomes of alternative treatment procedures. Also, when choosing a treatment alternative, special circumstances such as the patients overall health, body habitus, and other medical problems need to be taken into consideration by the treating physician.
REATMENT RECOMMENDATIONS
The AUA Nephrolithiasis Clinical Guidelines Panel considered, in its recommendations, a total of five methods for managing struvite staghorn calculi including watchful waiting or observation, as well as the four active modalities: (1) open surgery, (2) percutaneous nephrolithotomy (PNL), (3) extracorporeal shock-wave lithotripsy (SWL), and (4) combinations of PNL and SWL.
Levels of flexibility
The panel graded recommendations for treatment by three levels of flexibility, based primarily on the strength of the scientific evidence for estimating outcomes of interventions. A standard is defined as the least flexible of the three; a guideline, more flexible; and an option, the most flexible. These three levels of flexibility [Eddy, 1992] for treatment recommendations are defined on page 5.
The patient
Panel recommendations for the treatment of staghorn calculi apply to standard and nonstandard patients whose stones are presumed to be composed of struvite (magnesium ammonium phosphate).
2
RECOMMENDATIONS
Standards 1. As a standard, a newly diagnosed struvite staghorn calculus represents an indication for active treatment intervention. Although this recommendation was not formally subjected to data abstracting and statistical methods, the panel strongly believes based on expert opinion that a policy of watchful waiting and observation is not in the best interest of the standard patient with struvite staghorn calculi. As a standard, a patient with a newly diagnosed struvite staghorn calculus must be informed about the four accepted active treatment modalities, including the relative benefits and risks associated with each of these treatments.
2.
1.
As a guideline, percutaneous stone removal, followed by shock-wave lithotripsy and/or repeat percutaneous procedures as warranted, should be utilized for most standard patients with struvite staghorn calculi, with percutaneous lithotripsy being the first part of the combination therapy. As a guideline, shock-wave lithotripsy monotherapy should not be used for most standard patients as a first-line treatment choice. As a guideline, open surgery (nephrolithotomy by any method) should not be used for most standard patients as a first-line treatment choice.
Guidelines
2. 3.
Options 1. As options, shock-wave lithotripsy monotherapy and percutaneous lithotripsy monotherapy are equally effective treatment choices for small-volume struvite staghorn calculi in collecting systems which are of normal or near normal anatomy. As an option, open surgery is an appropriate treatment alternative in unusual situations where a staghorn calculus is not expected to be removable by a reasonable number of percutaneous lithotripsy and/or shock-wave lithotripsy procedures. As an option for a patient with a poorly functioning, stone-bearing kidney, nephrectomy is a reasonable treatment alternative.
2.
3.
A standard patient is defined as an adult patient who has two functioning kidneys (function of both kidneys relatively equal) or a solitary kidney with substantially normal function, and whose overall medical condition, body habitus, and anatomy permit performance of any of the four accepted active treatment modalities including use of anesthesia. A nonstandard patient is defined as one with a struvite staghorn stone who does not fulfill the above criteria. For this patient, the choice of available treatment options may be limited to three or even fewer of the four accepted active treatment modalities, depending on individual circumstances. The recommended standards and guidelines on page 3 apply to the treatment of standard patients, followed by options for nonstandard patients.
IN THE TREATMENT LITERATURE
LIMITATIONS
Limitations to the process of developing treatment recommendations became apparent during the panels review of the literature. Most obviously, for the purpose of this document, there is no uniform system of categorizing staghorn calculi, no
standard method of describing the collecting system, and no widely accepted system of reporting the size of staghorn calculi. Few prospective, randomized, controlled studies have been conducted concerning the treatment of struvite staghorn calculi. In addition, there is no uniform system in the literature for reporting outcomes following treatment for struvite staghorn calculi. Further uncertainty stems from differences in health care delivery systems in various countries as they impact the outcomes reported in the literature. Variability in the data leads to uncertainty in outcome estimates, which leads to flexibility in recommendations. This limitation applies to a variety of outcomes. Notwithstanding these limitations, the panel believes that the standards, guidelines, and options presented are well supported by the data reviewed. Recommendations are founded primarily on the data and partially on the expert opinion of panel members. Outcomes for which there is considerable uncertainty are clearly identified as such in the document. Whenever the panels expert opinion prevailed over the limited amount of available data, this is specified in the document as well.
Chapter 1: Methodology
The recommendations in this Report on the Management of Staghorn Calculi were developed following an explicit approach to the development of practice policies [Eddy, 1992], as opposed to an implicit approach relying solely on expert opinion without any open description of the evidence considered. The explicit approach attempts to provide mechanisms for arriving at recommendations that take into account the relevant factors for making selections between alternative interventions. Such factors include estimation of the outcomes from the interventions, consideration of patient preferences, and assessing when possible the relative priority of the interventions for a share of limited health care resources. Emphasis is placed on the use of scientific evidence in estimating the outcomes of the interventions. In developing the recommendations in this report, an extensive effort was made to review the literature on staghorn stones and to estimate the outcomes of the alternative treatment modalities as accurately as possible. The Nephrolithiasis Clinical Guidelines Panel members themselves served as proxies for patients in considering preferences with regard to health and economic outcomes. The review of the evidence began with a literature search and extraction of data as described below. The data available in the literature were displayed in evidence tables. From these tables, the panel developed estimates of the outcomes from the various interventions (shock-wave lithotripsy, percutaneous nephrolithotomy, combination shock-wave lithotripsy percutaneous stone removal and open removal). The panel used the FAST* PRO meta-analysis package as described below to combine the evidence from the various studies. These estimates of outcomes are arrayed on the balance sheet on page 13. The panel generated recommendations based on the outcomes shown in the balance sheet. These recommendations were graded according to three levels of flexibility, based on the strength of the evidence and on amount of variation in patient preferences. The three levels of flexibility for treatment recommendations [Eddy, 1992] are defined as follows: 1. Standard: A treatment policy is considered a standard if the health and economic outcomes of the alternative interventions are sufficiently well-known to permit meaningful decisions and there is virtual unanimity about which intervention is preferred. 2. Guideline: A policy is considered a guideline if the health and economic outcomes of the interventions are sufficiently well-known to permit meaningful decisions, and an appreciable but not unanimous majority agree on which intervention is preferred. 3. Option: A policy is considered an option if (1) the health and economic outcomes of the interventions are not sufficiently well-known to permit meaningful decisions, (2) preferences among the outcomes are not known, (3) patients preferences are divided among the alternative interventions, and/or (4) patients are indifferent about the alternative interventions. A standard has the least flexibility as a treatment policy. A guideline has significantly more flexibility, and options are even more flexible. As noted in the definitions, options can exist because of insufficient evidence or because patient preferences are divided. In the latter case particularly, the panel considered it important to take into account likely preferences of individual patients when selecting from among alternative interventions.
LITERATURE
SEARCH
A literature search was performed utilizing MEDLINE. Articles retrieved from MEDLINE included all manuscripts related to renal calculi published from 1966-1992. Articles prior to 1966 were identified by hand searching bibliographies and reference lists from other articles. Completeness of the search was confirmed by cross-checking indices of important journals. Journals deemed important, but not listed on MEDLINE (such as The Journal of Endourology), were also searched. The total yield was 1,250 articles. The specifics of the MEDLINE search criteria are included in the Technical Supplement.
All of the citations were imported into a Papyrus Bibliography System (Research Software Design, Portland, OR) and assigned specific keywords. Once keywords had been associated with each article, the articles could be sorted according to the mode of therapy (for example, medical or surgical), the stone location (renal or ureteral), and the primary mode of stone removal (for example, SWL vs. PNL vs. COMBO vs. OPEN). For reasons of practicality and validity, the panel decided that only articles from peer-reviewed journals in English-language literature would be utilized in the analysis. Prior to initiating abstraction of the articles, further searching of MEDLINE was performed with particular emphasis on the most recent articles on staghorn calculi. All pertinent stone articles as of January 1993 were included in the analysis. Search criteria from the Papyrus program to select appropriate articles for review were: keywords = CALCULI; KIDNEY; SURGICAL; RENAL; and STAGHORN. Further review by the entire panel of the 479 articles that met the initial search criteria yielded 110 articles with 136 differentiated groups of patients. These were articles containing viable data not duplicated in another manuscript. The articles are listed in Table A-1 and are the basis for the panels analysis of staghorn calculi.
committee of the panel to ensure accuracy. Figure A-1, on page A.1 in Appendix A, represents the number of articles reviewed by the panel by year. Figure A-2 demonstrates the source of articles from the English-language literature. The majority of articles came from The Journal of Urology, Urology, The Journal of Endourology, and The British Journal of Urology. Figure A-3 on page A.2 shows the breakdown of articles selected for review and Figures A-4 and A-5, the breakdown of selected articles stratified by staghorn calculi and by treatment modalities, respectively.
EVIDENCE
COMBINATION
ARTICLE
SELECTION AND DATA EXTRACTION
After identifying articles from the MEDLINE database and entering them into the Papyrus program, the panel reviewed the abstracts and selected the relevant citations for data extraction. A comprehensive data-extraction form was devised by the panel to capture as much pertinent information as possible from each article. A sample of the form is in Appendix B. The selected articles were divided among the panel members who then reviewed the articles and transcribed the data onto the form. Panel members reported that there is little consistency in the kidney stone literature in reporting outcomes data. All articles used to complete the report were reviewed by at least two panel members for accuracy. All articles excluded were by decision of the panel as a group. The forms from both reviews were forwarded to the panel facilitator, and any discrepancies in the data were resolved. All data were then entered into a PARADOX database. All computer entries were reviewed again by a sub-
In order to generate a balance sheet, estimates of the probabilities and/or magnitudes of the outcomes are required for each alternative intervention. Ideally, these come from a synthesis of the evidence. This synthesis or combination of the evidence can be performed in a variety of ways depending on the nature and quality of the evidence. For example, if there is one good randomized controlled trial, the results of that one trial alone may be used in the balance sheet. Other studies of significantly lesser quality would be ignored. If there are no studies of satisfactory quality for certain balance sheet cells or the studies found are not commensurable, then expert opinion is used to fill in those cells. If a number of studies have some degree of relevance to a particular cell or cells, then meta-analytic mathematical methods may be used. Different specific methods are available depending on the nature of the evidence. For this Report on the Management of Staghorn Calculi, the AUA elected to use the confidence profile method [Eddy, 1989; Eddy, Hasselblad, and Shachter, 1990], which provides methods for analyzing data from studies that are not randomized controlled trials. The FAST*PRO computer package [Eddy and Hasselblad, 1992] was used in the analysis. Because there are few randomized controlled trials for staghorn stones, the package was used to combine the single arms from various clinical series to estimate the outcome for each intervention. The series that were combined frequently showed very different results implying site-tosite variations that may be caused by differences in patient populations, in how the intervention was performed, or in the skill of those performing the intervention. Because of the differences, a ran-
dom-effects, or hierarchical, model was used to combine the studies. A random-effects model assumes that for each site there is an underlying true rate for the outcomes being assessed. It further assumes that this underlying rate varies from site to site. This siteto-site variation in the true rate is assumed to be normally distributed. The method of meta-analysis used in analyzing the staghorn data attempts to determine this underlying distribution. The results of the confidence-profile method are probability distributions. They can be described using a mean or median probability with a confidence interval. In this case, the 95-percent confidence interval is such that the probability (Bayesian) of the true value being outside the interval is 5 percent. The probability distribution can be displayed graphically (as a density function). This graph indicates the probability of any interval as the area under the graph on that interval. Thus, if a curve on a graph is very sharply peaked, the area under the curve is narrow indicating a narrow confidence interval. If a curve is relatively flat, this indicates a wide confidence interval. The total area under the graph is always equal to 1. The three graphs that follow illustrate a simple example of the use of the FAST*PRO software. Two studies looked at a certain outcome after a treatment for a given disease. In each study, 75 percent of the patients had the outcome. The first study had a total of 20 patients, and the second had a total of 1,000. If the software is used to update the probabilities for each site, the resultant (posterior) probability distributions of the true probability of the outcome can be graphed for each study.
Note that both curves in the graph center on 75 percent, but the curve for the first study is much flatter. There is a much larger uncertainty about the true value with 20 patients studied than with a sample of 1,000. Figure 2 adds a third study of 600 patients with 400 (66.7 percent) having the outcome. This study centers over a different point and is intermediate in height between the first two studies.
Probability
Figure 2. Confidence profiles for studies 1 (15 of 20 pts.), 2 (750 of 1000 pts.), and 3 (400 of 600 pts.)
If these studies are combined using the method described above, the result is a combined profile (Curve 4 in Figure 3). This profile is very narrow indicating that there is little difference among studies. Since two of the studies have the same result and the other is close, it is not surprising that there would be minimal site-to-site variation suggested by these studies.
Probability
Figure 3. Confidence profiles for studies 1, 2, and 3 and combined profile 4 (hierarchical Bayes)
Probability
Figure 1. Confidence profiles for studies 1 (15 of 20 pts.) and 2 (750 of 1000 pts.)
The method of computation is Bayesian in nature. This implies the assumption of a prior distribution that reflects knowledge about the probability of the outcome before the results of any experiments are known. The prior distributions
selected for this analysis are among a class of noninformative prior distributions, which means that they correspond to little or no preknowledge. The existence of such a prior can cause small changes in results, particularly for small studies. In the foregoing example, for instance, the mean of the distribution for the sample of size 20 is 0.74 rather than 0.75. The effect of the prior distribution is to slightly discount the value of the experiment. This effect will not be pronounced except in very small studies, and the combination of multiple studies will reduce this tendency further. For the statistically sophisticated reader, the prior distribution for all probability parameters is Jeffereys prior (beta distribution with both parameters set to 0.5). The prior for the variance for the underlying normal distribution is gamma distributed with both parameters set to 0.5. In addition to graphical presentations, 95-percent confidence intervals are used to present results. The medians and 95-percent confidence intervals for the results of the three foregoing sample studies and the combination are as follows: Outcomes considered important to patients receiving treatment for nephrolithiasis were analyzed in such fashion. In some cases, surrogates for patient outcomes were analyzed for example, stone-free rate as a surrogate for symptom improvement. Evidence from all studies meeting inclusion criteria that reported a certain outcome were combined within each treatment modality. Graphs showing the combined results for each
modality are also presented as an estimate of the difference between the modalities. With regard to certain outcomes, more data have been reported for one or another treatment modality. This results in a sharper and narrower peak in the graph reflecting the available data. However, the probability for certain outcomes can vary widely from study to study within one treatment modality. Such variability will result in a wide, flat combined distribution, which reflects considerable uncertainty about the outcome or considerable differences between sites and practitioners.
Study 1 2 3 Combination
Median .746 .750 .667 .716
95% CI .536 - .898 .722 - .776 .628 - .703 .687 - .743
As mentioned previously, there are few randomized controlled trials for staghorn stones. Thus, the differences seen by comparing studies as done here may be biased to some degree. For example, differences in patient selection may have had more weight in yielding the results shown than the differing effects of the treatment modalities. However, these results reflect the best outcome estimates known at the present time.
Chapter 2: Staghorn calculi and their management

BACKGROUND
Staghorn calculi are stones that fill the major part of the collecting system. Typically, such stones will occupy the renal pelvis, and branches of the stone will extend into the majority of the calices. The term partial staghorn is often used when a lesser portion of the collecting system is occupied by stone. There is, unfortunately, no agreement on how these terms should be defined, and the term staghorn is often used irrespective of the percentage of the collecting system occupied. There is also no widely accepted way to express the size of a staghorn calculus. As a result, stones of widely different volumes are all referred to as staghorns. Staghorn calculi are usually made of struvite (magnesium ammonium phosphate) with variable amounts of calcium, but stones made of cystine, calcium oxalate monohydrate, and uric acid can all fill the collecting system. Such stones are frequently found intermixed with struvite calculi in many series reported in the literature. The majority of staghorn stones are composed of struvite. These stones tend to be soft, and their radiologic appearance varies from relatively faint to moderately radiopaque. It is generally possible to predict on the basis of a plain x-ray film that a staghorn stone is composed of struvite. These stones are also called infected stones or infection stones because they occur only in the presence of urinary tract infection and only when the infection is secondary to organisms that elaborate the enzyme urease, which splits urea [Bruce and Griffith, 1981]. Cultures of pieces of struvite stones, taken both from the surface and from inside, have demonstrated that bacteria reside inside the stones and that the stones themselves are infected in contrast to stones made of cystine, calcium oxalate monohydrate, or other substances [Nemoy and Stamey, 1971]. An untreated struvite staghorn calculus will in time destroy the kidney, and the stone has a significant chance of causing the death of the affected patient [Rous and Turner, 1977; Koga, Arakai, Matsuoka, et al., 1991]. Moreover, struvite stones must be removed in their entirety to be certain of eradicating all of the infected stone material. If all of the infected material is not removed, the patient will continue to have recurrent urinary tract infections and the stone will eventually regrow. It may be possible to sterilize small amounts of struvite, but how much of the stone can be sterilized is uncertain and unpredictable [Pode, Lenkovsky, Shapiro, et al., 1988; Michaels and Fowler, 1991].
TREATMENT
METHODS
Four modalities reported in the literature are acceptable as potential alternatives for treating patients with struvite staghorn calculi: Open surgery referring to any method of open surgical exposure of the kidney and removal of stones from the collecting system; Percutaneous nephrolithotomy (PNL); Extracorporeal shock-wave lithotripsy (SWL); and Combinations of PNL and SWL.
Open surgery
Open surgical removal of the stone has been the so-called gold-standard, to which all other forms of stone removal have been compared. A variety of specific operations on the kidney may be performed in order to remove a staghorn calculus. Depending on anatomy, a pelviolithotomy, extended pyelotomy, nephrotomy, partial nephrectomy, or even nephrectomy may all play a role in specific cases. The most common operation performed today is anatrophic nephrolithotomy, and this is reflected in the literature over the past 20 years [Assimos, Boyce, Harrison, et al., 1989]. Anatrophic nephrolithotomy is usually performed with the patient in the flank position. A standard flank incision is made and frequently a rib is resected. After surgical exposure of the kidney, an incision is made lengthwise, bivalving the kidney and exposing the stone. Direct inspection and the use of intraoperative x-rays demonstrate that the kidney is stone free. The time allowed for removal of the stone is short, unless the kidney is cooled. The principles of the operation are well
established, with usual operating times of 3-7 hours. If the patient has had previous renal surgery, the operation may be more difficult [Stubbs, Resnick, and Boyce, 1978]. Hospitalizations of 7-14 days are the rule. In addition to the usual morbidity associated with any operation, flank incisions are painful and probably more painful than midline abdominal incisions. Many patients complain of numbness, paresthesia, and weakness of the abdominal wall resulting in bulging, which may be unsightly. The average postoperative disability is six weeks. This is based on the fact that a typical incision has regained about 80 percent of its preoperative strength by then, but recent work suggests that months may pass before many patients feel completely normal [Assimos, Wrenn, Harrison, et al., 1991]. Occasionally, the stone has caused enough damage to a kidney that nephrectomy is indicated. Such kidneys reveal the effects of years of chronic infection, episodes of acute pyelonephritis, and hydronephrosis [Assimos, Boyce, Harrison, et al., 1989].
The procedure may be divided into two parts, access and stone removal. To achieve percutaneous access, the urologist or radiologist places a small flexible guide wire, under fluoroscopic control, through the patients flank into the kidney and down the ureter. Care is taken to optimize the approach to the kidney so that the best approach to the stone is obtained. Once access is achieved, the tract is dilated to 24-30 F. and the nephroscope introduced. Under direct vision, the stone is broken up (usually with an ultrasonic probe) and the pieces removed. One of the characteristics of struvite is that the stone is usually soft, and fragmentation with removal of the pieces is often quick. PNL has unquestioned advantages: (1) If the stone can be seen, it can almost always be destroyed. (2) The collecting system may be directly inspected so that small fragments may be identified and removed. (3) Because the tract can be kept open indefinitely, repeated inspections are possible. (4) The process is rapid, with success or lack of it being obvious immediately. Hospitalizations are usually from 4-10 days with most patients returning to light activity after 1-2 weeks. Transfusion rates for PNL in treating staghorn calculi vary from 5 to 50 percent. Retreatment rates that is, the rate at which the instrument must be reinserted through the tract to remove residual stones vary from 10 percent in simple situations to 40-50 percent for more complicated problems. Stone-free rates of 75-90 percent are regularly achievable using PNL. One disadvantage is that the expertise required for this operation is not as widely available as it once was, because a greater number of urology training programs are focusing less on PNL and more on shock-wave lithotripsy for stone management.
The development of anatrophic nephrolithotomy and the demonstration that patients with infected stones could be stone free made an excellent case for this surgical approach, which became the standard throughout the 1960s and 1970s. In 1994, the incidence of open surgery for the treatment of all stones is about 1-2 percent. Staghorn calculi comprise most of the indications. The decision in favor of nephrectomy is usually made when the contralateral kidney is normal or nearly so, and when there is poor function in the affected kidney.
Percutaneous stone removal

Percutaneous nephrolithotomy (PNL), which became popular as a primary technique for stone removal in the early 1980s (Appendix C, page C.3), can theoretically be used for all stones. In practice, extracorporeal shock-wave lithotripsy (SWL) is used in the majority of situations where PNL was once employed. Struvite staghorn calculi, however, are often best managed by PNL either as a single technique or in combination with SWL.
10
Extracorporeal shock-wave lithotripsy

Shock-wave lithotripsy (SWL) has become the standard method for management of many calculi in the urinary tract (Appendix C, page C.1). SWL is based on the principle that a high-pressure shock wave will release energy when passing through areas of different acoustic impedance. Shock waves generated outside the body can be focused
onto a stone using a variety of geometric techniques. The shock wave passes through the body without trauma and releases its energy as it passes into the stone. Hundreds, or sometimes thousands, of such shock waves are required to break up the average small stone, with the goal being to reduce the size of the stone to particles small enough to pass without significant pain. There are many different shock-wave machines available today. Although they are based on the same general principle, there are significant differences that relate to the use of these machines for treatment of large stones such as staghorn calculi. The original machine, the Dornier HM-3, probably the most common machine throughout the world, has the largest focal point and, in its unmodified version, the highest power of all current devices. In an effort to reduce the anesthesia requirement, newer machines often have less power and smaller focal points. This means that stones treated with such machines will often require more procedures to achieve the same result produced with fewer procedures by other devices. Obviously, for very large stones, multiple treatments may be required. Shock-wave lithotripsy has few short-term complications, its noninvasive nature has much appeal, and the technique is widely available. SWL has disadvantages, however, particularly in regard to the management of staghorns. The panel found, as stated on pages 14 and 19, a relatively higher risk of residual fragments following initial treatment and a high probability of unplanned secondary procedures.
Combination PNL and SWL

Some stones can be best managed by using both PNL and SWL on the same stone. This combines the main advantage of percutaneous ultrasonic lithotripsy, that of removing rapidly large volumes of easily accessible stone, with the advantage of SWL in easily treating small volumes of stone that are difficult or dangerous to access using PNL. The surgeon first utilizes PNL, making every effort to remove as much stone as possible, before using SWL. Experience has demonstrated that following SWL, the passage of fragments cannot be predicted. Therefore, depending upon the extent and location of residual stones, repeat SWL and/or repeat PNL may be necessary to remove residual fragments.
Ancillary procedures
Percutaneous nephrostomy tube placement (PNTP) may be necessary at any point in the management of staghorn stones. It is a routine part of PNL, of course, and is frequently used after SWL for drainage of an infected stone and for pain relief when obstruction is present. Preliminary stent insertion prior to SWL for staghorn calculi is so common as to be part of the procedure. Frequently a double-pigtail stent is placed and left indwelling for days or weeks to maintain drainage while fragments pass. Irrigations of the collecting system with solutions such as Renacidin to dissolve remaining fragments of infected stones, particularly after PNL, have been advocated by some. This is not a common procedure, probably because it often means added hospitalization. The panel did not find sufficient evidence in the literature to support the use of Renacidin as a primary procedure for treating infected stones. Ureteroscopy may be needed to remove fragments too large to pass spontaneously. General or regional anesthesia is necessary, but success rates are very high (95 percent or greater). Most often, ureteroscopy is an outpatient procedure.
Because multiple treatments may be needed, use of SWL may not be practical to provide the required frequency of service if only mobile SWL is available and ancillary procedures directed toward the management of fragments are necessary. In addition, although many factors bear on the cost of any medical procedure, at the present time SWL is often more expensive than endourology or open surgery for the same condition [Hatziandreu, Carlson, Mulley, et al., 1990].
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Chapter 3: Outcomes analysis for staghorn treatment alternatives

DIRECT
AND INDIRECT OUTCOMES
Any therapeutic medical intervention has a certain set of outcomes, some of which are desirable (benefits) and some of which are not (harms) [Eddy, 1990]. Direct health outcomes are those felt directly by the patient and have an impact on the quantity or quality of life. Indirect biologic outcomes are physiologic end points such as absence of infection or incidence of stone recurrence. These may be of great importance to the clinical researcher. Also, physicians, in general, believe that outcomes such as absence of residual stones, prevention of stone recurrence, and limitation of residual stone growth are of the greatest importance when assessing treatment options for staghorn calculi, although patients may not view these outcomes per se as important end points. An example of the difference between the two types of outcomes is illustrated by the patient with a recent myocardial infarction. Although the level of the CPK enzyme is an important parameter for the physician (indirect biologic outcome), it cannot be felt by the patient in any way. Meanwhile, the chest pain or death associated with the infarction has an immediate impact on the patients quality or quantity of life (direct health outcome). Similarly, in treatment of staghorn calculi, the patient may not be interested in the stone-free rate, the chance of developing recurrent stones, or the incidence of growth of residual calculi following stone removal, despite the critical importance of these parameters to the physician unless the implications of the parameters are explained to the patient. However, the patient will very likely be interested in direct outcomes such as the degree of symptom improvement after treatment, the complications or side effects of treatment, mortality, and the cost and duration of hospital stay. For patients to participate in a shared decision-making process regarding treatment, they must be fully aware not only of the magnitude of the direct outcomes related to treatment alternatives, but also of the range of uncertainty associated with these outcomes. Indirect biologic outcomes can occasionally serve as proxies for direct health outcomes. The
incidence of infection may serve as a proxy for the degree of symptom improvement after treatment, and stone-free rate is used as a proxy for stone recurrence and symptom recurrence because these data are not available in the current literature.
COMBINING
OUTCOME EVIDENCE
The panel conducted a comprehensive review of the English-language literature and combined all outcome evidence for given treatment options, utilizing the confidence profile method as described on pages 6-8 of Chapter 1. The results of the combined review are presented in the balance sheet table on page 13. Outcomes with a wide confidence interval indicate considerable uncertainty in the medical knowledge base. This uncertainty is due either to a limited number of studies reported for a given intervention (as is the case for combination therapy) or to a wide variation in outcome probability reported in different studies (as is the case for shock-wave lithotripsy therapy). The short duration of many studies introduces uncertainty as well. The combined analysis is also weakened by the quality of the individual studies. As noted previously, there are currently few randomized, prospective controlled studies of staghorn calculi therapy in the literature. Therefore, most of the data analyzed by the panel come from clinical series. The limitations of including these types of studies are obvious. Nevertheless, if clinical series were not included, nothing could be said about the benefits and harms of various types of surgical removal of staghorn calculi. Further limitations arise from differences in study populations. In many cases, it is likely that patients who are entered into trials of alternative therapies have less severe disease states than those undergoing surgery. Moreover, the definition of staghorn calculi may differ significantly among various investigators, and some of the reports regarding the management of staghorn calculi do not specify the size of the stones or portion of the collecting system occupied. Thus, not all studies may be comparing treatment outcomes of stones of sim-
12
ilar size, composition, or location within the kidney. In these cases, the panel attempted to extrapolate from existing information to equate the treatment outcomes. Despite such limitations, the panel is reasonably certain that the confidence intervals contain the true probability of a given outcome for most sites. Better estimates, narrower confidence intervals, and greater certainty about treatment differences can be obtained through large, well-controlled studies that test the different therapies in the same patient population. However, until these types of outcome studies are completed, guidance can still be given to the physicians and patients who are forced to make decisions at the present time.
the median of an array of individual study results. In some cases, combined analysis could not be performed because of the way outcomes were reported in the literature.
ANALYSIS OF THE BALANCE SHEET OUTCOMES

The following sections discuss in detail the analysis used to generate the data on the balance sheet. The information is organized in relation to outcomes listed on the left side of the balance sheet, beginning with stone-free rate. Tables in addition to those from Appendix A (A-1 - A-21), referenced in this chapter, are contained in the Technical Supplement available upon request. These additional tables include FAST*PRO analysis tables.
THE
BALANCE SHEET
The balance sheet table details the results of an exhaustive combined analysis of the staghorn calculi treatment literature. In most cases, a 95-percent confidence interval is reported along with the median probability. This median both as given in the balance sheet and as referred to in the outcome analysis discussion that follows is the median of the probability distribution resulting from the meta-analysis of outcome data. It is not
Stone-free rate
To assess successful outcomes following various modalities of stone removal, one can determine the resolution of symptoms, absence of infection, or inhibition of recurrent stone formation or stone growth. However, most urologists would agree that the stone-free rate following stone removal is the most quantifiable and meaningful determinant of successful treatment.
Combined SWL and Percutaneous Nephrolithotomy

Balance sheet: outcomes of treatments for staghorn kidney stones Percutaneous Nephrolithotomy
Outcomes SWL Open Surgery Stone-free rate: Median 0.500 0.733 0.808 0.816 95% confidence interval 0.256-0.744 0.547-0.874 0.678-0.905 0.566-0.957 Acute complications: Overall significant complications:* Median 0.308 0.074 0.244 0.119 95% confidence interval 0.022-0.816 0.003-0.322 0.039-0.611 0.006-0.465 Transfusion: Median 0.009 0.108 0.120 0.089 95% confidence interval 0.002-0.022 0.003-0.478 0.052-0.222 0.078-0.101 Death: Median 0.0007 0.001 0.002 0.006 95% confidence interval 0.00006-0.003 0.0001-0.005 0.0001-0.006 0.004-0.009 Procedures/pt.: Primary 2.122 1.486 2.768 1.026 Secondary 0.424 0.047 0.034 0.002 Long-term complications: Stone recurrence: Median 0.058 0.068 No data 0.120 95% confidence interval 0.016-0.161 0.015-0.176 0.036-0.269 Stone growth: Median No data 0.070 No data 0.083 95% confidence interval 0.026-0.142 0.030-0.171 Renal impairment: Median No data No data No data 0.063 95% confidence interval 0.021-0.138 Loss of kidney: Median No data 0.016 No data 0.037 95% confidence interval 0.001-0.061 0.011-0.086 No. hospital days 8.72 10.09 12.73 10.99 * Hydrothorax, pneumothorax, perirenal hematoma, vascular injury, urinoma, secondary unplanned interventions, sepsis, loss of kidney. 13
Much of the literature regarding stone-free rate has been clouded in the age of shock-wave lithotripsy by studies that include patients with small residual fragments (so-called clinically insignificant residual fragments) together with patients who are truly stone free. Also, the method of assessing the stone-free state has a significant impact on the number of patients who are free of stones following surgery. Several studies evaluating different methods of assessing stone-free status conclude that a plain abdominal radiograph (KUB) may significantly underestimate the incidence of residual fragments, as compared to plain renal tomograms or ultrasonography [Denstedt, Clayman, and Picus, 1991; Jewett, Bombardier, Caron, et al., 1992]. Direct vision nephroscopy has the highest sensitivity rate for assessing stone-free status, but it is the most invasive method of residual stone determination. The majority of the studies included in the present analysis utilized only a plain abdominal radiograph to assess residual fragments. Therefore, the stonefree figures are probably overestimated. A total of 26 studies utilizing SWL monotherapy to manage staghorn calculi were analyzed, representing a total of 1,669 patients or renal units. The median stone-free rate for this group was 0.50 (95% CI 0.256 - 0.744). The studies included in the analysis are listed in Table A-2, Appendix A. The type of SWL machine may impact the stone-free rates for staghorn calculi. The higherpowered lithotripters (the electrohydraulic Dornier HM-3 and the electromagnetic Siemens Lithostar) impart significantly more energy to fragment the stones than do the piezoelectric devices (Wolf 2300 and EDAP). Although only data from two piezoelectric machines are included in this analysis, their stone-free rates appear to be significantly lower than those reported for the other lithotripsy devices (Table A-2). The stone-free data for PNL monotherapy are listed in Table A-3 and represent a total of 14 studies in 511 renal units. The FAST*PRO analysis calculated the median stone-free rate at 0.733 (95% CI 0.547 - 0.874). The stone-free rates for combination percutaneous stone removal and shock-wave lithotripsy treatment of staghorn calculi are listed in Table A-4. This group represents five studies reporting on 796 patients. The stone-free rate for the group was 0.808 (95% CI 0.678 - 0.905) using FAST*PRO analysis. Thirty-one studies reported stone-free rates in 2,487 patients using open surgical techniques
(Table A-5). It should be noted that the open surgical procedures included simple pyelolithotomy, extended pyelolithotomy, combination pyelolithotomy with radial nephrotomies, as well as a formal anatrophic nephrolithotomy. Analysis of these studies revealed a median stone-free rate of 0.816 (95% CI 0.566 - 0.957) using FAST*PRO. Comparative analysis using the FAST*PRO program for the four different surgical modes of stone removal is represented in Figure 4. The findings demonstrate, not surprisingly, that stone-free rates increase as the invasiveness of the surgical procedure increases. If, indeed, stone-free figures are used to ultimately decide the most appropriate mode of stone removal, open surgery should provide the best results. Moreover, this comparative analysis should demonstrate to the patient that although shock-wave lithotripsy monotherapy might be the least morbid of the surgical modalities, it definitely provides the lowest stone-free rates of the available treatment options.

Probability
Figure 4. Staghorn stone-free rates
Acute complications
The data abstraction sheet (Appendix B) lists a number of acute complications. They include perforation of the renal pelvis, hydrothorax/pneumothorax, perirenal hematoma, significant blood loss, vascular injury, transfusion, urinoma, sepsis, stent migration, renal impairment, wound infection, loss of kidney, and death. Secondary, unplanned interventions were also considered by the panel to be acute complications. In reviewing all studies for which there were data regarding acute complications, it became obvious to the panel that three major acute complications would most concern the patient as well as the physician: (1) the need for secondary, unplanned interventions, (2) the need for transfusion, and
14
(3) death. Data for these three major complications are listed separately in Appendix A (Tables A-6, A-7, A-8, and A-9). Secondary, unplanned interventions were not analyzed by FAST*PRO separately, but were combined with other acute complications for inclusion in the balance sheet under Overall Significant Complications. Transfusion and death were analyzed by FAST*PRO separately, and median probabilities and 95-percent confidence intervals for these two outcomes appear separately on the balance sheet. Table A-6 gives the acute-complications data for shock-wave lithotripsy monotherapy used to treat staghorn calculi. The FAST*PRO analysis shows, for overall significant complications in patients undergoing SWL monotherapy for staghorn calculi, a relatively high median rate of 0.308 (95% CI 0.022 - 0.816). A major contributor to this high overall rate was the high percentage of secondary, unplanned interventions shown in Table A-6. The median transfusion rate for SWL monotherapy was 0.009 (95% CI 0.002 - 0.022). The percentage of deaths following SWL monotherapy, when initially assessed, was found to be 0.13 percent. This mortality rate was based on one reported death in a population of 771 patients for whom acute complications were reported (Table A-6). The panel believed that the resulting percentage was clinically too high and that the reason may have been that many studies of SWL monotherapy for staghorn stones did not report acute complications, thereby lowering the denominator used in the calculation. The mortality rate was recalculated using a patient denominator of all patients undergoing SWL monotherapy for staghorn calculi (1,681 patients), rather than only those for whom acute complications were reported. (The panel assumed that if a patient had died during any clinical study of SWL monotherapy to treat staghorn calculi, the death would surely have been reported.) The recalculation dropped the mortality rate to 0.06 percent, which is more consistent with the panels perception of mortality from SWL monotherapy. FAST* PRO analysis of mortality for the balance sheet produced a median of 0.0007 (95% CI 0.00006 0.003). For PNL monotherapy of staghorn calculi (11 studies, 921 patients), the median rate for overall significant complications was 0.074 (95% CI 0.003 - 0.322). Listings in Appendix A are in Table A-7. There were seven secondary, unplanned interventions in the total of 921 PNL patients (Table A-7), making the percentage of secondary, un-
planned interventions for this percutaneous group significantly less than for SWL monotherapy. The median transfusion rate for PNL, however, was 0.108 (95% CI 0.003 - 0.478), significantly higher than for SWL. The median mortality rate for PNL was also much higher at .0011 (95% CI .0001 .0045). The data suggest that the more invasive percutaneous procedure results in higher transfusion and death rates than SWL monotherapy does. The number of secondary, unplanned interventions, however, was significantly higher in the SWL group, which suggests problems with incomplete stone removal secondary to SWL. The panel analyzed five studies that utilized combination percutaneous and shock-wave lithotripsy treatment for staghorn calculi. For the 781 patients represented, where data for acute complications were available, the percentage of overall significant complications was 23.94 percent (Table A-8). This included a secondary, unplanned intervention rate of 1.62 percent. FAST*PRO analysis of data from the combination PNL-SWL group yielded the following balance-sheet estimates: for overall significant complications, a median rate of 0.244 (95% CI 0.039 0.611); for transfusion, a median rate of 0.120 (95% CI 0.052 - 0.222); for mortality, a median rate of 0.002 (95% CI 0.0001 - 0.006). Acute complications were reported in 27 studies of open surgery for staghorn calculi, representing 2,314 patients. Of these 2,314 patients, 27.53 percent experienced overall significant complications (Table A-9), of which 0.30 percent represented secondary, unplanned interventions. The FAST*PRO analysis yielded a median rate of 0.119 (95% CI 0.006 - 0.465) for overall significant complications following open surgery for staghorns. The median transfusion rate was 0.089 (95% CI 0.078 - 0.101), and the median rate for mortality was 0.006 (95% CI 0.004 - 0.009). Acute-complications data overall for the four modalities of stone removal show the more invasive modalities, such as open surgery and percutaneous stone removal, with higher rates of transfusion and death than the rates for the less invasive therapy of shock-wave lithotripsy. However, as noted previously, shock-wave lithotripsy monotherapy of staghorn calculi was followed by many more secondary, unplanned interventions. The panel believes that this is a significant finding since these secondary, unplanned interventions resulted in increased patient morbidity as well as increased cost for stone removal. Figures 5-7 display
15
FAST*PRO graphical analyses comparing the four modalities with regard to overall significant complications, transfusions, and death.
Procedures per patient (primary and secondary)

An important outcome on the balance sheet, in comparing the various surgical modes of staghorn stone removal, analyzes the number of procedures performed per patient to achieve a successful result. Before 1979, when open surgery was the only modality available to treat struvite staghorn calculi, it was unusual to perform more than one procedure per patient to remove all stone material. However, in an age of less invasive techniques for stone removal, the need for repeat primary and, in some cases, secondary procedures has significantly increased in order to attempt complete removal of the stone material. A total of 16 studies using SWL monotherapy were available for analysis, representing 835 patients. These individuals underwent 1,772 primary SWL procedures, 2.12 per patient (Table A-10). In total, the 835 SWL patients underwent 2,126 procedures, which represented an additional 0.42 secondary procedures per patient (Table A-10). Thus, the advantage of reduced invasiveness for SWL therapy for staghorn calculi resulted in a total of 2.55 procedures per patient including both primary and secondary SWL procedures as well as additional procedures which included percutaneous nephrostomy tube placement, ureteroscopy, and in some cases open surgery. Twenty-three studies that reported SWL monotherapy of staghorn stones were not included in this analysis of procedures per patient because they reported on less than five patients or did not contain specific information on numbers of procedures per patient. In the PNL group, 10 studies met entrance criteria. They represent a total of 854 patients. These patients underwent 1,269 primary percutaneous stone removal procedures, for a primary procedure rate of 1.49 per patient. The 854 patients underwent a total of 1,309 procedures, including an additional 0.05 secondary procedures per patient (Table A-11). The total procedures-per-patient rate of 1.53 was significantly less than the total procedures-per-patient rate of 2.55 seen with the SWL monotherapy group. Ten additional PNL studies were not included in this analysis because no specific data were presented regarding the number of procedures per patient or because the study sample was less than five patients. In the combination therapy group, six studies met entrance criteria, representing 168 patients (Table A-12). These patients underwent a total of 222 percutaneous procedures and 243 SWL procedures, representing a 2.77 primary procedures-per-
Probability
Figure 5. Overall significant complications: Comparison of modalities

Probability
Figure 6. Transfusions: Comparison of modalities
Probability
Figure 7. Death: Comparison of modalities
16
patient rate. By definition, in the combination therapy group, which includes management of the staghorn stone by both percutaneous and shockwave lithotripsy, the minimum procedures-perpatient rate would be 2.0. An additional 0.03 procedures per patient were performed in the combination group, yielding a total procedures-per-patient rate of 2.80 (Table A-12). As one would expect, the number of procedures per patient in the open surgery group was the lowest of all four modalities for stone removal. Table A-13 presents the 27 studies. They represent 1,672 procedures on 1,630 patients for a primary procedure rate of 1.03 per patient. With secondary procedures, a total of 1,676 procedures were performed in this group of patients. The total procedures-per-patient rate remained at 1.03 (rounded off), as the number of additional procedures per patient was only 0.002. Most series of open surgery were reported before 1980, prior to the availability of percutaneous surgery and shock-wave lithotripsy. This explains the low secondary procedure rate, reflecting reluctance of the surgeon and the patient to repeat open surgical procedures. Twenty-five studies were excluded from the analysis of procedures per patient in the open group because there were fewer than five patients or because of not providing specific data regarding the numbers of procedures per patient.
recurrence rate, 0.120 (95% CI 0.036 - 0.269), than the median rates for the SWL and PNL groups. A small number of patients in the open group were found to have growth of their residual stones, yielding a median stone growth rate of 0.083 (95% CI 0.030 - 0.171). Renal impairment during longterm follow-up was a median 0.063 (95% CI 0.021 - 0.138), and 21 of the 1,549 patients eventually lost a kidney (Table A-16). No data on long-term complications were reported for the combination PNL-SWL group. It should be noted that renal impairment or loss of kidney may not necessarily be due directly to stone removal, but may be secondary to other factors.
Probability
Figure 8. Stone recurrence: All modalities combined
Long-term complications
The long-term complications reported for the four modes of stone removal included stone recurrence, stone growth, renal impairment, and loss of kidney following surgery. Unfortunately, only a small amount of data was available from the studies analyzed regarding these long-term complications. Only one SWL monotherapy study reported stone recurrence in 3 of their 54 patients (Table A-14), yielding a FAST*PRO median recurrent stone rate of 0.058 (95% CI 0.016 - 0.161). Analysis of the percutaneous monotherapy group of studies (Table A-15), also with a limited number of patients (93), yielded a median rate of stone recurrence of 0.068 (95% CI 0.015 - 0.l76) as well as a median rate of stone growth of 0.070 (95% CI 0.026 - 0.142). One of the 93 patients in the PNL group had a long-term complication of renal loss. A significant amount of information was reported in the studies of open surgery, with data on 1,549 patients for whom long-term complications were noted (Table A-16). FAST*PRO analysis of the open group yielded a higher median stone
17
It appears that the open surgery group had the highest rate of stone recurrence, but in comparison with very scanty data presented for the SWL and PNL series. The discrepancy is probably due to the fact that a larger number of open studies have investigated the long-term results of this form of stone removal. SWL and PNL studies, for the most part, have only reported short-term follow-up. The panel anticipates that, if followed long enough, the PNL, SWL, and combination groups will show rates of stone recurrence and growth similar to
Probability
Figure 9. Stone growth: All modalities combined
Probability
Figure 10. Loss of kidney: All modalities combined
those in the open series. One would not expect the mode of stone removal to have any effect on a patients propensity for recurrent stone formation or growth of residual stone fragments. Median rates for long-term complications are graphed in Figures 8-10.
Hospital days
Any form of surgical stone removal for staghorn calculi, including the least invasive option of shock-wave lithotripsy, may require patient hospitalization. The data on hospital days was directly extracted from the literature and included in the balance sheet. In the case of SWL and of combination therapy, the total hospitalization may not represent continuous stay within the hospital. For example, the patient might have been hospitalized for 1-3 days the first time, discharged, and then readmitted for a second or third treatment. The hospital days represent a cumulative total of the reported hospital stay for each modality. Hospitalization practices vary from country to country and change over time. No attempt was made to correct for varying practices of this type. All of the hospital data are somewhat exaggerated by current standards. For patients with staghorn calculi undergoing SWL monotherapy, a total of seven studies, repre-
senting 305 patients and 2,660 hospital days, met appropriate criteria and were included for analysis (Table A-17). An additional 30 studies were excluded because they did not meet appropriate criteria for analysis. They either did not report hospital days or reported less than five patients. Six studies, representing 247 patients who had undergone percutaneous monotherapy for staghorn stones, and representing 2,493 days, met analysis criteria and are listed in Table A-18. Fourteen studies of percutaneous monotherapy were excluded from analysis due either to low numbers of patients or to nonreporting of hospitalization. Table A-19 defines the five studies utilizing combination shock-wave lithotripsy and percutaneous stone removal for the management of staghorn stones in 775 patients, for a total of 9,869 hospital days. One combination study was excluded from analysis due to nonreporting of hospitalization. Of the patients with staghorn calculi treated with open surgery, nine studies met entrance criteria for analysis, representing 1,354 patients and 14,886 patient days (Table A-20). In 42 studies where patients had undergone open therapy for staghorn calculi, hospitalization data were not presented and could not be analyzed. Hospitalization was highest for the combination therapy groups (12.73 hospital days), probably due to the increased number of procedures performed on each patient. Although the hospitalization data for the shock-wave lithotripsy monotherapy group seem somewhat high at 8.72 hospital days, it should be noted that these were complex staghorn calculi being treated with shock-wave monotherapy with an average of approximately 2.5 procedures per patient. Moreover, five of the seven studies included in the SWL monotherapy group were performed outside the U. S. (Table A-21), where there is less incentive to minimize hospitalization than in the U. S. health care system.
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Chapter 4: Staghorn treatment recommendations

There are five methods of managing staghorn calculi. One is by watchful waiting (observation). The other four are the active treatment modalities described in Chapter 2 and in greater detail in Appendix C. They are (1) open surgery, (2) percutaneous nephrolithotomy (PNL), (3) extracorporeal shock-wave lithotripsy (SWL), and (4) combinations of PNL and SWL. The panels recommendations regarding use of these modalities to treat struvite staghorn calculi are based on the outcomes analysis presented in detail in Chapter 3.
OUTCOMES AND TREATMENT RECOMMENDATIONS
TREATMENT
The panel concluded, from reviewing the literature and analyzing the data, that the following outcome probabilities are the most significant in setting forth recommendations for treatment of struvite staghorn calculi: The probability of being stone free following treatment; The probability of undergoing secondary, unplanned procedures; and
The probability of having complications associated with the chosen primary treatment modality. The four modalities of open surgery, PNL, SWL, and combination PNL and SWL are all reasonable treatment alternatives for patients with struvite staghorn calculi. However, outcome probabilities differ markedly among the four. The following statements are based on both statistical analysis of abstracted data from the treatment literature and expert opinion. They form the basis of the panels recommendations: The risk of having residual fragments following initial treatment is clearly higher after shock-wave lithotripsy monotherapy than after percutaneous nephrolithotomy, combination therapy, or open surgery. It is the expert opinion of the panel that residual fragments of infected calculi left in the renal collecting system may be associated with recurrent infections and eventual regrowth of these fragments into significant stones leading to additional morbidity, although literature to support this opinion is scarce.
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Shock-wave lithotripsy monotherapy carries a high probability of unplanned secondary procedures. Percutaneous nephrolithotomy, combination therapy, and open surgery are more likely to require general or regional anesthesia. The chance that a blood transfusion will be required is greater for percutaneous nephrolithotomy, combination therapy, and open surgery than for shock-wave lithotripsy monotherapy. Rates of complications following the four treatment modalities differ significantly for each modality. From the patients viewpoint, a complication may have the same importance as a secondary, unplanned procedure, inasmuch as it may require a second anesthetic procedure or prolong the patients hospital stay. Therefore, an analysis combining secondary, unplanned procedures and the complications associated with the primary treatment modalities chosen may accurately reflect the patients viewpoint regarding desirability or undesirability of a given intervention. Of all four treatment modalities, shock-wave lithotripsy monotherapy has the highest combined complication and secondary, unplanned intervention rate. However, the complications associated with shock-wave lithotripsy monotherapy tend to be less severe than those associated with percutaneous nephrolithotomy, combination therapy, or open surgery. The peer-reviewed literature does not stratify outcomes appropriately by either size or composition of staghorn calculi or the anatomy of the collecting system. Nevertheless, the panel believes that these factors impact the outcomes of alternative treatment procedures. Also, when choosing a treatment alternative, special circumstances such as the patients overall health, body habitus, and other medical problems need to be taken into consideration by the treating physician.
THE
PATIENT
Panel recommendations for the treatment of staghorn calculi apply to standard and nonstandard patients whose stones are presumed to be composed of struvite (magnesium ammonium phosphate).
A standard patient is defined as an adult patient who has two functioning kidneys (function of both kidneys relatively equal) or a solitary kidney with substantially normal function, and whose overall medical condition, body habitus, and anatomy permit performance of any of the four accepted active treatment modalities including use of anesthesia. A nonstandard patient is defined as one with a struvite staghorn stone who does not fulfill the above criteria. For this patient, the choice of available treatment options may be limited to three or even fewer of the four accepted active treatment modalities, depending on individual circumstances. The standards and guidelines recommended by the panel apply to the treatment of standard patients, followed by options for nonstandard patients. The terms standards, guidelines, and options, as used in the panels recommendations, refer to the three levels of flexibility for treatment policies. A standard is the least flexible of the three, a guideline more flexible, and an option the most flexible.
RECOMMENDATIONS: STANDARDS
1. As a standard, a newly diagnosed struvite staghorn calculus represents an indication for active treatment intervention. Although this recommendation was not formally subjected to data abstracting and statistical methods, the panel strongly believes based on expert opinion that a policy of watchful waiting and observation is not in the best interest of the standard patient with struvite staghorn calculi. In previous years, some physicians thought that patients with staghorn stones were better left untreated, without efforts to remove the stone [Libertino, Newman, Lytton, et al., 1971]. This idea was based on the concept that staghorn calculi were likely to be asymptomatic except for bacteriuria and that if symptoms were few, it was hard to justify the aggressive surgical procedures necessary to render the patient stone free. Review of the literature, however, reveals that few patients do well without the removal of their stones [Rous and Turner, 1977]. At the Mayo Clinic, the histories of 382 patients with staghorn calculi were reviewed [Priestly and Dunn, 1949]. Two hundred and thirty-four patients had only a unilateral staghorn calculus. In these patients, the survival rate was only 41 percent for
those treated with observation alone compared to 81 percent for those who underwent nephrolithotomy. Another study [Blandy and Singh, 1976] reviewed a group of 185 patients with staghorn calculi. Sixty of these patients were treated with observation alone, and 125 had surgical removal of their stones. The operated group had a 7.2-percent mortality rate over a 10-year period, but 28 percent of those in the observation-only group died over that period. Significant hydronephrosis was noted in another 15 percent. In a recent study of 167 patients, 61 of whom were followed for an average of nearly eight years, one-third had chronic renal failure secondary to bilateral staghorn stones and seven died of uremia [Koga, Arakaki, Matsuoka, et al., 1991]. Twentyfive percent had nephrectomy revealing changes of hydronephrosis, abscess, and pyelonephritis. It is clear that left untreated, a struvite staghorn will eventually destroy the kidney. Patients will usually have recurrent urinary tract infections, episodes of sepsis, and pain. Also, the stone has a significant chance of causing death in the affected patients. Nonsurgical treatment, that is, management with antibiotics and supportive measures only, is not considered a viable option except in those patients otherwise too ill to tolerate stone removal. 2. As a standard, a patient with a newly diagnosed struvite staghorn calculus must be informed about the four accepted active treatment modalities, including the relative benefits and risks associated with each of these treatments. Although, as a practical matter, it is evident that the availability of equipment and the expertise of an individual practitioner may impact the choice of a treatment intervention, it is unacceptable to withhold certain treatments from the patient and not offer them as alternatives because of personal inexperience or unfamiliarity with one of the accepted treatment modalities, or because of the local unavailability of equipment or expertise.
RECOMMENDATIONS: GUIDELINES
1. As a guideline, percutaneous stone removal, followed by shock-wave lithotripsy and/or repeat percutaneous procedures as warranted, should be utilized for most standard patients with struvite staghorn calculi, with percutaneous lithotripsy being the first part of the combination therapy.
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2. As a guideline, shock-wave lithotripsy monotherapy should not be used for most standard patients as a first-line treatment choice. 3. As a guideline, open surgery (nephrolithotomy by any method) should not be used for most standard patients as a first-line treatment choice.
RECOMMENDATIONS: OPTIONS
1. As options, shock-wave lithotripsy monotherapy and percutaneous lithotripsy monotherapy are equally effective treatment choices for smallvolume struvite staghorn calculi in collecting systems which are of normal or near normal anatomy. 2. As an option, open surgery is an appropriate treatment alternative in unusual situations where a staghorn calculus is not expected to be removable by a reasonable number of percutaneous lithotripsy and/or shock-wave lithotripsy procedures. 3. As an option for a patient with a poorly functioning, stone-bearing kidney, nephrectomy is a reasonable treatment alternative.
RECOMMENDATION
Limitations to the process of developing treatment recommendations became apparent during the panels review of the literature. Most obviously, for the purpose of this document, there is no uniform system of categorizing staghorn calculi, no standard method of describing the collecting system, and no widely accepted system of reporting the size of staghorn calculi. Few prospective, randomized, controlled studies have been conducted concerning the treatment of struvite staghorn calculi. In addition, there is no uniform system in the literature for reporting outcomes following treatment for struvite staghorn calculi. Further uncertainty stems from differences in health care delivery systems in various countries as they impact the outcomes reported in the literature. Variability in the data leads to uncertainty in outcome estimates, which leads to flexibility in recommendations. This limitation applies to a variety of outcomes. Also, in most of the papers reviewed for this document, the unmodified Dornier HM-3 was used

LIMITATIONS
for shock-wave lithotripsy. Future studies in which other machines are used, as monotherapy or in combination with other modalities, could change the results of treatment requirements. Notwithstanding these limitations, the panel believes that the standards, guidelines, and options presented are well supported by the data reviewed. Recommendations are founded primarily on the data and partially on the expert opinion of panel members. Outcomes for which there is considerable uncertainty are clearly identified as such in the document. Whenever the panels expert opinion prevailed over the limited amount of available data, this is specified in the document as well. Panel recommendations are made with the knowledge that they have not undergone review by the public. Further, the panel acknowledges that although issues of expense may have a bearing on treatment choices, the panel is unable to address this aspect of the problem at the present time. Moreover, to date, no patient preference analysis has been performed to validate the recommendations of the panel. Rather, the panel acted as patient advocate and recommended treatment choices based on the balance sheet while acting as a proxy patient. The panel realizes that this method is less than ideal and may not reflect the thinking of actual patients, but it is currently the method most available to formulate treatment recommendations.
BASIC
RESEARCH NEEDS
Four basic improvements are needed to build a more solid foundation for future research on staghorn calculi: 1. A consistent method of classifying staghorn calculi needs to be devised, including an accepted system for reporting size. 2. A consistent method of describing the collecting system also needs to be devised. 3. Uniform methods of reporting outcomes are needed. For example, in reporting stone-free rates, distinctions need to be made between stone free and stone free with insignificant residual fragments. 4. Parameters need to be established for stratifying study results in terms of demographic data for example, in terms of a study populations size and composition.
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References*
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*Articles
that were selected for review, abstracted, included in evidence tables, and stratified by staghorn calculi, for meta-analysis of outcome data, are preceded by an asterisk (*). These articles, 110 in total, are also listed in Table A1 in Appendix A.
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36. Dretler SP, Watson G, Parrish JA, Murray S. Pulsed dye laser fragmentation of ureteral calculi: initial clinical experience. J Urol 1987;137:386-9. 37. Eddy DM. The confidence profile method: a Bayesian method for assessing health technologies. Oper Res 1989;37(2):210-28. 38. Eddy DM. Clinical decision making: from theory to practice. Comparing benefits and harms: the balance sheet. JAMA 1990;263:2493-2505. 39. Eddy, DM. A manual for assessing health practices & designing practice policies: the explicit approach. Philadelphia (PA): American College of Physicians; 1992. 126 p. 40. Eddy DM, Hasselblad V. FAST*PRO. Software for meta-analysis by the confidence profile method. San Diego: Academic Press, Inc. Harcourt Brace Jovanovich; 1992. 196 p. 41. Eddy DM, Hasselblad, V, Shachter, R. A Bayesian method for synthesizing evidence: the confidence profile method. Int J Technol Assess Health Care 1990;6:31-55. 42. * Eshghi AM, Roth JS, Smith AD. Percutaneous transperitoneal approach to a pelvic kidney for endourological removal of staghorn calculus. J Urol 1985;134:525-7. 43. * Eshghi M, Smith AD. Endourologic approach to transplant kidney. Urology 1986;28:504-7. 44. * Farcon EM, Morales P, Al-Askari S. In vivo hypothermic perfusion during renal surgery. Urology 1974;3:414-20. 45. Feagins BA, Wilson WT, Preminger GM. Intracorporeal electrohydraulic lithotripsy with flexible ureterorenoscopy. J Endourol 1990;4:347-51. 46. * Fiorentini L, Minervini R, Palla R, Bianchi C. The effect of bivalve nephrotomy on renal function in patients with staghorn calculi. J Nucl Med Allied Sci 1980;24:159-61.
58. * James R, Novick AC, Straffon RA, Stewart BH. Anatrophic nephrolithotomy for removal of staghorn or branched renal calculi. Urology 1980;15:108-11. 59. Jewett MAS, Bombardier C, Caron D, Ryan MR, Gray RR, St. Louis EL, Witchell SJ, Kumra S, Psihramis KE. Potential for inter-observer and intra-observer variability in x-ray review to establish stone-free rates after lithotripsy. J Urol 1992;147:55962. 60. * Kahnoski RJ, Lingeman JE, Coury TA, Steele RE, Mosbaugh PG. Combined percutaneous and extracorporeal shock wave lithotripsy for staghorn calculi: an alternative to anatrophic nephrolithotomy. J Urol 1986;135:679-81.
61. * Katz G, Meretyk S, Verstandig A, Sharpiro A. Persistence of matrix material in urinary collecting system after extracorporeal shock wave lithotripsy. J Endourol 1990;4:235-9. 62. * Kawamura J, Itoh H, Okada Y, Higashi Y, Yoshida O, Fujita T, Torizuka K. Preoperative and postoperative cortical function of the kidney with staghorn calculi assessed by 99 mtechnetiumdimercaptosuccinic acid renal scintigraphy. J Urol 1983;130:4303. 63. * Kerlan RK Jr, Kahn RK, Laberge JM, Pogany AC, Ring EJ. Percutaneous removal of renal staghorn calculi. Am J Roentgenol 1985;145:797-801. 64. * Koga S, Arakaki Y, Matsuoka M, Ohyama C. Staghorn calculi long-term results of management. Br J Urol 1991;68:122-4. 65. * Korth K, Bernius U. Percutaneous litholapaxy. Urol Int 1986;41:375-84. 66. * Lalude AO, Martin DC. Renal arteriovenous fistula: a complication of anatrophic nephrolithotomy. J Urol 1983;130:754-6. 67. * Lam HS, Lingeman JE, Barron M, Newman DM, Mosbaugh PG, Steele RE, Knapp PM, Scott JW, Nyhuis A, Woods JR. Staghorn calculi: analysis of treatment results between initial percutaneous nephrostolithotomy and extracorporeal shock wave lithotripsy monotherapy with reference to surface area. J Urol 1992;147:1219-25. 68. * Lam HS, Lingeman JE, Mosbaugh PG, Steele RE, Knapp PM, Scott JW, Newman DM. Evolution of the technique of combination therapy for staghorn calculi: a decreasing role for extracorporeal shock wave lithotripsy. J Urol 1992;148:1058-62. 69. * Lazare JN, Saltzman B, Sotolongo J. Extracorporeal shock wave lithotripsy treatment of spinal cord injury patients. J Urol 1988;140:266-9. 70. * Lee WJ, Snyder JA, Smith AD. Staghorn calculi: endourologic management in 120 patients. Radiology 1987;165:85-8. 71. * Libertino JA, Newman HR, Lytton B, Weiss RM. Staghorn calculi in solitary kidneys. J Urol 1971;105:753-7. 72. * Liston TG, Montgomery BSI, Bultitude MI, Tiptaft RC. Extracorporeal shock wave lithotripsy with the Storz Modulith SL20: the first 500 patients. Br J Urol 1992;69:465-9. 73. * Mahmood P, Morales PA. Extended pyelolithotomy (Gil Vernets pyelotomy). J Urol 1973;109:772-4. 74. * Marshall VF, Lavengood RW Jr, Kelly D. Complete longitudinal nephrolithotomy and the Shorr regimen in the management of staghorn calculi. Ann Surg 1965;162:366-73. 75. * Martin X, Salas M, Labeeuw M, Pozet N, Gelet A, Dubernard JM. Cystine stones: the impact of new treatment. Br J Urol 1991;68:234-9. 76. * Matsuoka K, Ueda S, Eto K. A clinical study of percutaneous nephroureterolithotripsy. Kurume Med J 1990;37:247-51.
47. * Fuchs AM, Wolfson BA, Fuchs GJ. Staghorn stone treatment with extracorporeal shock wave lithotripsy monotherapy: longterm results. J Endourol 1991;5:45-8. 48. * Giuliani L, Martorana G, Giberti C, Pescatore D. Bivalve nephrolithotomy in kidneys with ileal ureter. J Urol 1979;122:815-16.
49. * Gleeson M, Lerner SP, Griffith DP. Treatment of staghorn calculi with extracorporeal shock-wave lithotripsy and percutaneous nephrolithotomy. Urology 1991;38:145-51. 50. Green DF, Lytton B. Early experience with direct vision electrohydraulic lithotripsy of ureteral calculi. J Urol 1985;133:767-70. 51. * Harada M, Ko ZR, Kamidono S. Experience with extracorporeal shock wave lithotripsy for cystine calculi in 20 renal units. J Endourol 1992;6:213-15. 52. Hatziandreu EE, Carlson K, Mulley AG Jr, Weinstein MC. Costeffectiveness study of the extracorporeal shock-wave lithotriptor. Int J Technol Assess Health Care 1990;6:623-32. 53. Higashihara E, Horie S, Takeuchi T, Kameyama S, Asakage Y, Hosaka Y, Honma Y, Minowada S, Aso Y. Laser ureterolithotripsy with combined rigid and flexible ureterorenoscopy. J Urol 1990;143:273-4. 54. Hofmann R, Hartung R. Use of pulsed Nd:YAG laser in the ureter. Urol Clin North Am 1988;15:369-75. 55. * Hofmann R, Stoller ML. Endoscopic and open stone surgery in morbidly obese patients. J Urol 1992;148:1108-11. 56. Huffman JL. Early experience with the 8.5 F compact ureteroscope. Sur Endosc 1989;3:164-6. 57. * Hutchison AG. Cystine stones treated by surgery and D-penicillamine. Proc R Soc Med 1968;61:1144-6.
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77. * Mays N. Relative costs and cost-effectiveness of extracorporeal shock-wave lithotripsy versus percutaneous nephrolithotomy in the treatment of renal and ureteric stones. Soc Sci Med 1991;32:1401-12. 78. * McDonald DF. Surgical management of stag-horn renal calculi. South Med J 1974;67:1067-9. 79. Michaels EK, Fowler JE Jr. Extracorporeal shock wave lithotripsy for struvite renal calculi: prospective clinical study with extended follow-up. J Urol 1991;146:728-32. 80. * Middleton RG, Marshall VF. Complete longitudinal nephrolithotomy for staghorn calculi in children. J Urol 1971;106:776-9. 81. Morgentaler A, Bridge SS, Dretler SP. Management of the impacted ureteral calculus. J Urol 1990;143:263-6. 82. Nemoy NJ, Stamey TA. Surgical, bacteriological, and biochemical management of infection stones. JAMA 1971;215:470. 83. * Nemoy NJ, Stamey TA. Use of hemiacidrin in management of infection stones. J Urol 1976;116:693-5. 84. * Nesbitt JA, Drago JR, Wise HA II, Nelson JH III, Perez JF. Extracorporeal shock wave lithotripsy: first-year experience with 1360 patients. J Endourol 1988;2:235-40. 85. * Nijman RJM, Ackaert K, Scholtmeijer RJ, Lock TWTM, Schrder FH. Long-term results of extracorporeal shock wave lithotripsy in children. J Urol 1989;142:609-11. 86. Patel VJ. The coagulum pyelolithotomy. Br J Surg 1973;60:2306. 87. * Patterson DE, Segura JW, LeRoy AJ. Long-term follow-up of patients treated by percutaneous ultrasonic lithotripsy for struvite staghorn calculi. J Endourol 1987;1:177-80.
99. Preminger GM, Schultz S, Clayman RV, Curry T, Redman HC, Peters PC. Cephalad renal movement during percutaneous nephrostolithotomy. J Urol 1987;137:623-5. 100. Priestly JT, Dunn JH. Branched renal calculi. J Urol 1949;61:194-203. 101. * Puppo P, Bottino P, Germinale F, Caviglia C, Ricciotti G, Giuliani L. Percutaneous debulking of staghorn stones combined with extracorporeal shockwave lithotripsy: results and complications. Eur Urol 1988;15:18-25. 102. Raney AM. Electrohydraulic lithotripsy: experimental study and case reports with the stone disintegrator. J Urol 1975;113:345-7. 103. Raney AM, Handler J. Electrohydraulic nephrolithotripsy. Urology 1975;6:439-42. 104. * Redman JF, Bissada NK. Extensive nephrolithotomy in previously operated solitary kidneys. J Urol 1976;115:502-4. 105. * Redman JF, Bissada NK, Harper DL. Anatrophic nephrolithotomy: experience with a simplification of the Smith and Boyce technique. J Urol 1979;122:595-7. 106. * Regan JS, Lam HS, Lingeman JE. Simultaneous bilateral percutaneous nephrolithotomy. J Endourol 1992;6:245-7. 107. * Resnick MI, Boyce WH. Bilateral staghorn calculi-patient evaluation and management. J Urol 1980;123:338-41. 108. Resnick MI. The craft of urologic surgery. Pyelonephrolithotomy for removal of calculi from the inferior renal pole. Urol Clin North Am 1981;8:585-90. 109. Reuter HJ, Kern E. Electronic lithotripsy of ureteral calculi. J Urol 1973;110:181-3. 110. * Rigatti P, Francesca F, Montorsi F, Consonni P, Guazzoni G, Di Girolamo V. Extracorporeal lithotripsy and combined surgical procedures in the treatment of renoureteral stone disease: our experience with 2,955 patients. World Journal of Surgery 1989;13:765-75. 111. * Rodrigues Netto N Jr, Lemos GC, Palma PCR, Fiuza JL. Staghorn calculi: percutaneous versus anatrophic nephrolithotomy. Eur Urol 1988;15:9-12. 112. * Rous SN, Turner WR. Retrospective study of 95 patients with staghorn calculus disease. J Urol 1977;118:902-4. 113. * Rovinescu I, Blanger PM, Lapalme R. A new technique for removal of staghorn calculi. The pyelo-renal flap. Urol Int 1968;23:326-34. 114. * Russell JM, Harrison LH, Boyce, WH. Recurrent urolithiasis following anatrophic nephrolithotomy. J Urol 1981;125:471-4. 115. * Ruys JCA, Moonen WA. Our experiences dealing with one hundred patients with staghorn calculi. Arch Chir Neerl 1968;20:7-14. 116. * Ryan PC, Butler MR. EDAP LT01 lithotripter. J Endourol 1988;2:181-7. 117. * Schmeller NT, Kersting H, Schller J, Chaussy C, Schmiedt E. Combination of chemolysis and shock wave lithotripsy in the treatment of cystine renal calculi. J Urol 1984;131:434-8. 118. * Schulze H, Hertle L, Kutta A, Graff J, Senge T. Critical evaluation of treatment of staghorn calculi by percutaneous nephrolithotomy and extracorporeal shock wave lithotripsy. J Urol 1989;141:822-5. 119. Segura JW, Patterson DE, LeRoy AJ, Williams HJ Jr, Barrett DM, Benson RC Jr, May GR, Bender CE. Percutaneous removal of kidney stones: review of 1,000 cases. J Urol 1985;134:1077-81. 120. * Selli C, Carini M. Treatment of large renal calculi with extracorporeal shock wave lithotripsy monotherapy. Eur Urol 1988;15:161-5.
88. * Peiser J, Kaneti J, Lissmer L, Klain J, Blank C, Hertzanu Y. Perinephric inflammatory process following extracorporeal shock wave lithotripsy. Int Urol Nephrol 1991;23:107- 11. 89. * Petersen HK, Moller BB, Iversen HG. Regional hypothermia in renal surgery for severe lithiasis. Scand J Urol Nephrol 1977;11:27-34.
90. * Petersen SE, Olesen S, Jrgensen TM, Wolf H. Initial experience with percutaneous nephrolithotomy: results, problems and complications. Scand J Urol Nephrol Suppl 1987;104:145-50. 91. * Pettersson B, Tiselius H-G. One-year follow-up of unselected group of renal stone formers treated with extracorporeal shock wave lithotripsy. J Endourol 1989;3:19-30. 92. * Pettersson B, Tiselius H-G, Andersson A, Eriksson I. Evaluation of extracorporeal shock wave lithotripsy without anesthesia using a Dornier HM3 lithotriptor without technical modifications. J Urol 1989;142:1189-92.
93. * Pettersson B, Tiselius H-G, Carlsson P, Rahmqvist M. What do our patients have to endure in order to get their stones removed? Scand J Urol Nephrol Suppl 1989;122:29-33. 94. * Picus D, Weyman PJ, Clayman RV, McClennan BL. Intercostal-space nephrostomy for percutaneous stone removal. Am J Roengenol 1986;147:393-7. 95. * Pode D, Caine M, Pfau A, Shapiro A, Lencovsky Z, Katz G, Davidson JT. Shock-wave treatment for stones in the kidney and ureter. The Jerusalem experience. Isr J Med Sci 1987;23:243-8. 96. * Pode D, Lenkovsky Z, Shapiro A, Pfau A. Can extracorporeal shock wave lithotripsy eradicate persistent urinary infection associated with infected stones? J Urol 1988;140:257-9. 97. Preminger GM. Sonographic piezoelectric lithotripsy: more bang for your buck. J Endourol 1989;3:321-7. 98. Preminger GM, Roehrborn CG. Special applications of flexible deflectable ureterorenoscopy. Semin Urol 1989;7:16-24.
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121. * Shioshvili TI. Results of the clinical use of a dry kidneys hypothermia. Eur Urol 1977;3:154-8. 122. * Silber N, Kremer I, Gaton DD, Servadio C. Severe sepsis following extracorporeal shock wave lithotripsy. J Urol 1991;145:1045-6. 123. * Singh M, Marshall V, Blandy J. The residual renal stone. Br J Urol 1975;47:125-9. 124. * Singh M, Chapman R, Tresidder GC, Blandy J. The fate of the unoperated staghorn calculus. Br J Urol 1973;45:581-5. 125. * Singh M, Tresidder GC, Blandy J. The long-term results of removal of staghorn calculi by extended pyelolithotomy without cooling or renal artery occlusion. Br J Urol 1971;43:658-64. 126. * Smith MJV, Boyce WH. Anatrophic nephrotomy and plastic calyrhaphy. J Urol 1968;99:521-7. 127. * Spirnak JP, DeBaz BP, Green HY, Resnick MI. Complex struvite calculi treated by primary extracorporeal shock wave lithotripsy and chemolysis with hemiacidrin irrigation. J Urol 1988;140:1356-9. 128. * Stage KH, Lewis S. Pre- and postoperative evaluation of renal function in patients with staghorn calculi utilizing quantitative renal scanning. Urology 1981;17:29-32. 129. * Stenzl A, Fuchs GJ, Fuchs AM. Extracorporeal shock wave lithotripsy of pelvic allograft kidney. J Endourol 1988;2:19-22. 130. * Streem SB, Geisinger MA, Risius B, Zelch MG, Siegel SW. Endourologic sandwich therapy for extensive staghorn calculi. J Endourol 1987;1:253-9. 131. * Streem SB, Lammert G. Long-term efficacy of combination therapy for struvite staghorn calculi. J Urol 1992;147:563-6. 132. * Stubbs AJ, Resnick MI. Struvite staghorn calculi in crossed fused ectopia. J Urol 1977;118:369-71.
137. * Tth C, Holman E, Khan MA. Nephrostolithotomy monotherapy for staghorn calculi. J Endourol 1992;6:239-43. 138. * Valente R, Marini F, Signori G. Combined therapy of staghorn calculi with ureteroscopy and extracorporeal shock wave lithotripsy. Experience with 10 cases. Eur Urol 1988;14:349-52. 139. * Vanden Bossche M, Simon J, Schulman CC. Shock wave monotherapy of staghorn calculi. Eur Urol 1990;17:1-6. 140. * Vandeursen H, Baert L. Extracorporeal shock wave lithotripsy monotherapy for staghorn stones with the second generation lithotriptors. J Urol 1990;143:252-6. 141. * Vandeursen H, Devos P, Baert L. Electromagnetic extracorporeal shock wave lithotripsy in children. J Urol 1991;145:1229-31. 142. * Vargas AD, Bragin SD, Mendez R. Staghorn calculus: its clinical presentation, complications and management. J Urol 1982;127:860-2. 143. * Virgili G, Vespasiani G, Mearini E, Di Stasi SM, Micali F. Extracorporeal piezoelectric lithotripsy: experience in 930 patients. J Endourol 1992;6:309-14. 144. * Walton JK. A New Zealand experience of staghorn calculus surgery. Aust N Z J Surg 1978;48:301-3. 145. Weber HM, Miller K, Rschoff J, Gschwend J, Hautmann, RE. Alexandrite laser lithotripter in experimental and first clinical application. J Endourol 1991;5:51-5. 146. * Wickham JEA, Mathur VK. Hypothermia in the conservative surgery of renal disease. Br J Urol 1971;43:648-57. 147. * Winfield HN, Clayman RV, Chaussy CG, Weyman PJ, Fuchs GJ, Lupu AN. Monotherapy of staghorn renal calculi: a comparative study between percutaneous nephrolithotomy and extracorporeal shock wave lithotripsy. J Urol 1988;139:895-9. 148. * Wirth MP, Theiss M, Frohmuller HGW. Primary extracorporeal shock wave lithotripsy of staghorn renal calculi. Urol Int 1992;48:71-5. 149. * Woodhouse CRJ, Farrell CR, Paris AMI, Blandy JP. The place of extended pyelolithotomy (Gil-Vernet operation) in the management of renal staghorn calculi. Br J Urol 1981;53:520-3. 150. * Wulfsohn MA. Extended pyelolithotomy: the use of renal artery clamping and regional hypothermia. J Urol 1981;125:46770. 151. * Young AT, Hulbert JC, Cardella JF, Hunter DW, CastanedaZuniga WR, Reddy P, Amplatz K. Percutaneous nephrostolithotomy: application to staghorn calculi. Am J Roentgenol 1985;145:1265-9.
133. Stubbs AJ, Resnick MI, Boyce WH. Anatrophic nephrolithotomy in the solitary kidney. J Urol 1978;119:457-60.
134. * Thomas R, Lewis RW, Roberts JA. The renal quantitative scintillation camera study for determination of renal function after anatrophic nephrolithotomy. J Urol 1981;125:287-8. 135. * Thornhill JA, Moran K, Mooney EE, Sheehan S, Smith JM, Fitzpatrick JM. Extracorporeal shockwave lithotripsy monotherapy for paediatric urinary tract calculi. Br J Urol 1990;65:63840. 136. * Tombolini P, Mandressi A, Ruoppolo M, Dormia G, Trinchieri A, Zanetti G, Montanari E, and Pisani E. The percutaneous treatment of the cast, branched and staghorn renal stones. Contrib Nephrol 1987;58:270-3.
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Appendix C: Description of available techniques for management of renal and ureteral calculi
SHOCK-WAVE
LITHOTRIPSY
Since the first patient with a renal calculus was successfully treated with shock-wave lithotripsy in 1980, this form of stone therapy has rapidly gained widespread acceptance to become the treatment of choice for the majority of renal and ureteral calculi. Worldwide clinical series have documented the efficacy of shock-wave lithotripsy [Chaussy, Schmiedt, Jocham, et al., 1982; Brown and Preminger, 1988]. Shock waves are high-energy amplitudes of pressure generated in the air or water by an abrupt release of energy in a small space. They propagate according to the physical laws of acoustics and are transmitted through media with low attenuation. When a shock wave encounters a boundary between substances of differing acoustic impedance (density), compressive stresses are generated that may overcome the tensile strength of that object. Shock waves travel through water and the soft tissues of the body with low attenuation because these materials have similar densities. However, when kidney stones of any composition are contacted by a shock wave of sufficient energy, a compression wave is induced along the front face of the stone. As a result, the stone surface facing the shock wave begins to crumble. As a shock wave crosses the opposite surface of the stone, part of the energy is reflected, creating tensile stress and fragmentation. Repeated shock waves eventually reduce the stone to small fragments, ideally 2 mm or less in diameter, which may be passed spontaneously. Extensive clinical testing has determined that the compression tensile wave phenomenon results in an implosion rather than an explosion of the fragments and that the total kinetic energy of all fragments can be minimized by using a large number of relatively low-energy shock waves rather than fewer shocks of higher energy. Although the basic principles of shock-wave lithotripsy remain unchanged, a myriad of technological advances and modifications in the currently available lithotripters have significantly expanded the clinical applications. stone localization provided by biplanar fluoroscopy. Modifications of the four basic components of the HM-3 lithotripter have now provided a new class of lithotripters of which ten machines are currently either available commercially or undergoing clinical trials. This section on new instrumentation reviews the features and principal differences between these lithotripters with regard to shock-wave generation, focusing, patient coupling, and stone localization.
Shock-wave generation
The two basic types of energy sources for generating shock waves are point sources and extended sources. The electrohydraulic devices (Dornier, Direx, Medstone, Northgate, and Technomed) utilize point sources for energy generation, whereas extended sources are incorporated in the piezoelectric devices (Diasonics, EDAP, and Wolf) and the electromagnetic devices (Siemens). The electrohydraulic shock-wave generator is located at the base of a water bath and produces shock waves by an electric spark-gap of 15,000 to 25,000 volts of one microsecond duration. The high-voltage spark discharge produces rapid evaporation of water, which generates a shock wave by expanding the surrounding fluid at the first focal point (F1). This electrohydraulic generator is located within an ellipsoidal reflector that concentrates the reflected shock waves at the second focal point (F2). Multiple, repeated electrohydraulic shock waves from a first-generation machine produce pain at the skin level and within the focal region, thus requiring general or regional anesthesia during lithotripsy. Anesthesia-free second-generation electrohydraulic lithotripters have been developed by widening the aperture of the ellipse and decreasing the overall energy intensity of the shockwave generator. However, some form of analgesia, sedation, or local anesthesia is usually required with the majority of second-generation electrohydraulic lithotripters. Piezoelectric shock waves are generated by the sudden expansion of ceramic elements excited by a highfrequency, high-voltage energy pulse. The motion of the piezoceramic elements generates an ultrasonic wave which in turn produces a shock wave directed to the focal point. The shock wave is then propagated through either a water-filled bag (EDAP and Diasonics) or basin (Wolf). The spherical focusing mechanism of the piezoelectric lithotripters provides a wide region of shockwave entry at the skins surface and a very small focal region (4 x 8 mm in the Wolf lithotripter). The combination of a wide aperture of the focusing sphere, a larger
Lithotripter instrumentation
All lithotripters share four main features: an energy source, a focusing device, a coupling medium, and a stone-localization system. The original Dornier HM-3 design utilizes a spark plug energy generator with an elliptical reflector for focusing the shock waves. A water bath transmits the shock waves to the patient with
C. 1
skin-entry zone, a small focal region, and lower peak pressures generated by the piezoelectric machines has provided an anesthesia-free form of lithotripsy. In the electromagnetic device (Siemens), shock waves are generated when an electrical impulse moves a metallic membrane that is housed within a shock tube. The resulting shock wave produced in the water-filled shock tube cylinder is focused by an acoustic lens and coupled to the body surface with a water cushion. Some form of sedation and/or local anesthesia is usually required during treatment with this electromagnetic lithotripter due to the smaller aperture and moderate peak pressures generated. The Dornier DLC Compact lithotripter also utilizes an electromagnetic generator and is currently undergoing clinical trials in the U.S.
contrast material to help delineate the anatomy of the collecting system. However, fluoroscopy requires more space and carries the inherent risk of ionizing radiation to both the patient and medical staff. Ultrasonography is becoming an increasingly important modality for the urologist. Sonography-based lithotripters offer the advantages of stone localization with continuous monitoring and effective identification of radiolucent stones, without radiation exposure [Preminger, 1989]. Additionally, ultrasound has been documented to be effective in localizing stone fragments as small as 2-3 mm. The major disadvantages of ultrasound stone localization include the need for basic mastery of ultrasonic techniques by the urologist and the difficulty in localizing ureteral stones.
Shock-wave focusing
Once shock waves are generated, they must be focused on the target calculus. The method of focusing is dictated by the type of shock-wave generation. Machines that utilize point sources, such as the electrohydraulic lithotripters, generate shock waves that travel in an expanding circular pattern and require ellipsoidal reflectors for focusing the shock waves at the second focal point. The array of piezoceramic elements is positioned on a spherical disc, which allows focusing at a very small focal region, whereas the vibrating metal membranes of the electromechanical lithotripter produce an acoustical wave that requires a lens for focusing the shock wave.
Instrumentation for newer lithotripters

Currently, there are a number of lithotripters in clinical trials that attempt to incorporate many of the characteristics of an ideal lithotripter. The basic design of the newer machines includes dual-imaging capabilities as well as variable shock-wave power. Among these machines are the Dornier MFL 5000 (HM5), Dornier MPL 9000X, EDAP LT-02, Siemens Lithostar Plus, Storz, Modulith SL-20, and Wolf Piezolith 2500.
Coupling of the shock wave
Dual imaging
The coupling media currently utilized by the different lithotripters ranges from a 1,000-liter water bath to an enclosed water cushion. The water bath requires unique positioning of the patient in the tub so that the calculus is at the second focal point. Recent modifications in the patient gantry system of the first-generation Dornier HM-3 lithotripter have allowed the treatment of children as well as distal ureteral calculi. Second-generation machines have adopted designs for coupling that minimize the space requirements as well as the physiological and functional disadvantages of a large water bath. Current models use either an enclosed water cushion, a small exposed pool of water, or a totally contained shock tube. The water-filled cushions and shock tubes contain the shock-wave source, conditioned water, and a coupling membrane to allow simplified positioning and dry lithotripsy. However, the direct water-skin interface utilized by two units (Technomed and Wolf) is believed by some to offer improved shock-wave coupling.
Stone localization
Stone localization during lithotripsy is accomplished with either fluoroscopy or ultrasonography. Fluoroscopy provides the urologist with a familiar modality and has the added benefits of effective ureteral stone localization. Moreover, fluoroscopy facilitates the use of
C. 2
Dual-imaging capabilities entail having both fluoroscopic and sonographic localization systems available in the same machine. Such a design has the advantage of utilizing fluoroscopy for imaging stones within the kidney, as well as the ureter, while having the option to use sonography for the identification of radiolucent or biliary tract calculi. Moreover, sonographic capabilities allow one to initially target a stone using fluoroscopy and then switch over to ultrasound to avoid an excessive amount of ionizing radiation. Having fluoroscopy capabilities may also lessen the learning curve for many urologists who are unfamiliar with sonographic stonelocalization procedures. Interestingly, whereas the Dornier, Siemens, and Storz machines have all added ultrasound capabilities to provide dual imaging, none of these systems provides in-line imaging for both the fluoroscopic or sonographic localization devices. For example, with the Dornier and Siemens devices, one can utilize sonography to target a radiolucent or biliary tract calculus; yet the patient must be moved blindly to the fluoroscopy unit which is in-line with the shock-wave generator. Alternatively, it is possible to utilize the fluoroscopic localization system with the Storz machine, but only the ultrasound is in-line with the shock-wave generator. Of these devices, only the Wolf Piezolith 2500 and EDAP LT-02 at this time have both the fluoroscopy and sonography in-line with the piezoelectric shock-wave generator. This design permits rapidly changing from fluoroscopic to sonographic stone localization without moving the patient off the treatment dish.
Variable power
All six of the aforementioned third-generation devices have variable-power shock-wave generators that allow the operator to apply the appropriate amount of shock-wave energy for a particular stone. One can turn down the generator power to provide significantly reduced anesthesia/analgesia requirements with the Dornier, EDAP, Siemens, and Storz machines, as well as to provide totally anesthesia/analgesia-free lithotripsy with the Wolf device. Moreover, the shock-wave intensity can be increased with all four machines to allow adequate fragmentation of extremely hard or large calculi. However, when using these lithotripters in the high power mode, various forms of anesthesia/analgesia are necessary. So, in fact, no one has yet developed the ultimate shock wave which allows totally anesthesia-free lithotripsy with maximum efficiency. Yet, by varying the shock-wave energy, one can administer a highly efficient shock wave with the need for anesthesia/analgesia when high shock-wave pressures are indicated. On the other hand, with a small or soft stone, the shock-wave energy can be significantly decreased to provide minimal-anesthesia lithotripsy.
PERCUTANEOUS
Percutaneous endoscopic manipulation of stones in the renal collecting system, in its development, has no precedent in the history of urologic surgery. The technique evolved, within a decade, from a procedure undertaken by a few physicians to a procedure performed routinely by thousands of urologists worldwide only to then be forced into the background by an even more revolutionary procedure for stone treatment, namely shockwave lithotripsy.
Archived Document Modalities For Reference Only
NEPHROLITHOTOMY
then be passed directly into the renal collecting system to perform various manipulations. Endoscopy is begun by performing rigid or flexible nephroscopy. Although specially designed nephroscopes with a 30-degree side-arm viewing system are available, a traditional panendoscope of 24 F. is equally well suited for rigid nephroscopy and allows visualization and manipulation inside the renal collecting system. Once the renal pelvis and those calyces that are accessible to a rigid nephroscope have been visualized and the surgeon is familiar with the intrarenal anatomy, flexible nephroscopy can be performed to inspect individual calyces which may not be within reach of the rigid instrument. With the help of these flexible instruments, the entire collecting system can be visualized by taking advantage of the tip deflection and rotating the instrument inside the kidney. The internal diameter of the working sheath is usually 30 F., which equals about 1 cm. Therefore, stones up to this size can be extracted intact through the sheath. For the fragmentation of stones inside the renal collecting system (and the ureter) that are too large to be extracted (> 1 cm), three modalities of power lithotripsy are available: ultrasonic lithotripsy (UL), electrohydraulic lithotripsy (EHL), and laser lithotripsy. Two additional modalities are under FDA study: electromechanical impactor (EMI) and pneumatic lithotrite.
Ultrasonic lithotripsy
Techniques in percutaneous stone manipulation

Initially, a percutaneous nephrostomy tract needs to be established in order to gain access to the intrarenal collecting system. The access tract should enter the kidney through a posterior calyx, which is usually facilitated by positioning the patient at 30 degrees on the fluoroscopy table. In most cases, the lower or middle pole calyces may be accessed below the 12th rib, but occasionally a supracostal approach is necessary to optimally reach the targeted stone [Segura, Patterson, LeRoy, et al., 1985]. One should anticipate possible cephalad renal movement during nephrostomy access placement, which may alter the proposed approach [Preminger, Schultz, Clayman, et al., 1987]. The nephrostomy tract is then formed by dilating the skin, fascia, muscles, and renal tissues over the guide wire. Nephrostomy tract dilatation can be performed using graduated dilators or a balloon catheter. After the nephrostomy tract has been dilated up to a 30-F. (10-mm diameter) size, a hollow plastic sheath is placed into the renal pelvis. A variety of endoscopic instruments may
C. 3
Percutaneous lithotripsy to fragment kidney stones was first described in 1979 [Alken, 1982]. Commercially available units consist of a power generator and an ultrasound transducer and a probe, both forming the sonotrode. A piezoceramic element in the handle of the sonotrode is stimulated to resonate, and this converts electrical energy into ultrasound waves (with a frequency of 23,000-27,000 Hz) which then are transmitted along the hollow metal probe to create a vibrating action at its tip. When the vibrating tip is brought in contact with the surface of a stone, the calculus can be disintegrated. The probe must be rigid because sound waves cannot be transmitted without energy loss along flexible probes. The probes come in sizes of 10 F. and 12 F. and are passed through the straight working channel of a rigid nephroscope with an offset lens (24-F. or 26-F. nephroscope diameter). Suction tubing can be connected to the end of the sonotrode probe, thus converting the unit into a vacuum cleaner for stone fragments. Normal saline at body temperature should be used as irrigant. Ultrasonic lithotripsy is generally used for fragmentation of large renal stones. However, some uric acid, calcium oxalate monohydrate, or cystine stones may not break up easily, thereby necessitating EHL. Besides the risk for perforation and extravasation of irrigant, UL is associated with noise levels of around 90 dB several inches from the transducer. For lengthy UL sessions,
ear plugs are recommended. Depending on the location of the stones, retained fragments are seen in 3-35 percent of all cases treated with ultrasonic lithotripsy. This cannot be considered a failure in many cases because the UL is often performed for the debulking of large stones, to be followed by shock-wave lithotripsy as part of a planned two-stage procedure.
however, are for intraureteral fragmentation of stones and are discussed below in the section on ureteroscopy.
URETEROSCOPY
The advent of ureterorenoscopy has dramatically altered the management of symptomatic ureteral calculi. Rigid ureteroscopy has been used in conjunction with ultrasonic and electrohydraulic lithotripsy and pulseddye laser probes to successfully fragment ureteral calculi [Beck, Vaughan, and Sosa, 1989; Preminger and Roehrborn, 1989]. Improvements in fiberoptics and irrigation systems have fostered the use of smaller semirigid ureteroscopes (6.9 to 8.5 F.), but it has been mainly the introduction of the flexible deflectable ureterorenoscopes that makes access to the upper ureter and intrarenal collecting system a safer and less tedious procedure [Beck, Vaughan, and Sosa, 1989; Huffman, 1989; Preminger and Roehrborn, 1989]. The extremely small working channel of the semirigid and flexible instruments, which ranges from 2.4 to 4.0 F., has limited the size and usefulness of instruments that can be passed through these ureterorenoscopes and used for stone removal. Indeed, for larger stones in the proximal ureter, the 3-F. basket or grasping forceps are often inadequate to accomplish successful stone extraction. This limitation of available instrumentation has prompted the use of intracorporeal lithotripsy for the management of larger upper ureteral and intrarenal calculi. Currently the two most commonly employed methods for intracorporeal lithotripsy of ureteral stones, via the flexible or semirigid ureterorenoscope, are EHL and the pulsed dye laser. Ultrasonic lithotripsy is occasionally used for lower ureteral calculi, but its use has been supplanted to a large extent by EHL and laser lithotripsy. Although the choice of intracorporeal fragmentation is frequently based on the location and composition of the stone to be treated, the experience of the clinician and availability of equipment more often dictate this decision.
Electrohydraulic lithotripsy
The principles of electrohydraulic lithotripsy (EHL) were described and developed by a Russian engineer in 1950. This technology has been used extensively for the destruction of bladder stones, and in 1975 reports were published on its use for the fragmentation of kidney stones [Raney and Handler, 1975]. The EHL unit has a probe, a power generator, and a foot pedal. The probe consists of a central metal core and two layers of insulation with another metal layer between them. Probes are flexible and available in multiple sizes to be used through rigid and flexible nephroscopes. Commercially available EHL units are manufactured with power up to 120 volts. The electrical discharge is transmitted to the probe where it generates a spark at the tip. The intense heat production in the immediate area surrounding the tip results in a cavitation bubble which produces a shock wave that radiates spherically in all directions. Collapse of the bubble causes a second shock wave. These shock waves, repeated at a frequency of 50-100 per second, result in destruction of the stone. EHL will effectively fragment all kinds of urinary calculi including the very hard cystine, uric acid, and calcium oxalate monohydrate stones. Since the probes are small and flexible, they can be used through flexible nephroscopes and ureteroscopes to fragment stones in calyces inaccessible by UL through a rigid instrument. The primary disadvantage of EHL is its inability to efficiently remove the stone fragments. All particles have to be either washed out during intraoperative irrigation or grasped with forceps. It is advantageous to fragment the stone into the smallest number of particles that allow extraction with grasping devices (usually < 1 cm). There is no virtue in transforming a large stone into hundreds of small particles, or even sand-like material, because a significant amount of time is required to remove the debris. Overall, EHL should be the second choice for routine stone fragmentation in the kidney, but may be the procedure of choice in the ureter. Its main application should be for very hard stones or stones not within reach of the rigid nephroscope/UL probe.
Electrohydraulic lithotripsy
The first experience with electrohydraulic lithotripsy in the ureter entailed a 6-F. EHL probe which was fluoroscopically guided to the obstructing calculus [Reuter and Kern, 1973]. The most common cause of failure in this early experience was secondary to the operators inability to pass the probe to the level of the stone. Additional early experience with EHL within the ureter described the use of a 9-F. probe which provided excellent fragmentation of the stone. However, 40 percent of the patients had ureteral extravasation following the lithotripsy procedure [Raney, 1975]. This high complication rate was attributed to the large probe size. The use of a smaller 5-F. EHL probe through the rigid ureteroscope was compromised by decreased stone visualization because the probe occupied most of the working channel of the rigid ureteroscope [Green and Lytton, 1985].
Laser lithotripsy
Laser lithotripsy is the newest modality available for stone fragmentation. The 250-micron quartz fiber of the pulsed dye laser is easily passed through the smallest flexible nephroscope for treatment of renal calculi. The indications for use of laser lithotripsy on renal calculi are similar to those for use of EHL. Most applications,
C. 4
The development of a smaller 3-F. EHL probe, used through a flexible ureteroscope, was reported in 1988 [Begun, Jacobs, and Lawson, 1988]. Recently, a 1.9-F. EHL probe has been developed. It is quite successful in fragmenting ureteral and intrarenal stones. An additional benefit of these small-caliber probes is improved visualization through the flexible ureteroscope, as a larger portion of the working channel is available for irrigation [Denstedt and Clayman, 1990; Feagins, Wilson, and Preminger, 1990].
for laser lithotripsy units [Weber, Miller, Rschoff, et al., 1991].
OPEN
LITHOTOMY
Laser lithotripsy
As noted before, laser lithotripsy also is utilized for the management of ureteral calculi. The significant advances in laser fibers and power-generation systems have propelled laser lithotripsy, in many practitioners hands, the treatment of choice for ureteral stones [Dretler, 1987]. The pulsed dye laser delivers short one-microsecond pulsations at 5-10 Hz produced from a coumarin green dye. A plasma is formed at the stone surface, resulting in a highly localized shock wave. The 504-nanometer wave length produced by the dye laser is selectively absorbed by the stone and not the surrounding ureteral wall. Because the energy is delivered in short pulses, the heat generated is minimal, thus protecting the ureter [Coptcoat, Ison, Watson, et al., 1987; Dretler, 1987; Dretler, Watson, Parrish, et al., 1987]. Initial experience has yielded fragmentation rates from 64 to 95 percent [Hofmann and Hartung, 1988; Higashihara, Horie, Taksuchi, et al., 1990; Morgentaler, Bridge, and Dretler, 1990]. Failures have been related to equipment malfunction (4 to 19 percent) or more often to stone composition. Also, the use of EHL and/or basketing has been necessary as an adjunctive measure with the laser in some cases of successful stone removal. Use of the pulsed dye laser in the ureter in all series appears to be safe. No significant intraoperative or postoperative complications have been noted. Continued development of laser technology has yielded larger diameter laser fibers able to fragment hard calculi more effectively. Newer 300- and 320-micrometer fibers are superior to the 200-micrometer fibers in fragmentation of calcium oxalate monohydrate and cystine stones [Dretler and Bhatta, 1991]. Fragmentation rates of greater than 90 percent have been obtained with these new fibers. As the field continues to advance, new materials (alexandrite) are now being tested as sources
While percutaneous nephrolithotomy, shock-wave lithotripsy, and ureteroscopy have become widely embraced as treatments of choice for the majority of renal and ureteral calculi, the indications for open lithotomy have decreased dramatically. Given currently available technology, only 1-5 percent of stones now require an open procedure for removal. A recent study [Assimos, Boyce, Harrison, et al., 1989] found that, of 893 stone procedures performed since the introduction of lithotripsy at their institution, 4.1 percent required open lithotomy for renal calculi. The most common indication for open lithotomy was failure of lithotripsy or percutaneous nephrolithotomy. Morbidly obese patients often require open lithotomy. Their body habitus precludes fluoroscopic or sonographic localization or effective treatment of renal calculi because the shock waves become attenuated in the excess tissue. Also, the large amount of adipose tissue in the flank may prevent placement of an Amplatz sheath into the renal pelvis during percutaneous nephrostolithotomy. Stones in a collecting system with distal obstruction may require open lithotomy with concomitant pyeloplasty. In addition, obstructed or scarred calyceal infundibula can be repaired with calyorrhaphy or calycoplasty after removal of the stone [Resnick, 1981]. Coagulum pyelolithotomy may be helpful in patients with many small stones in multiple calyces. This procedure could also be of benefit for clearing small residual calculi in patients who have undergone anatrophic nephrolithotomy [Patel, 1973]. For branched renal calculi, surgical procedures beyond simple open pyelolithotomy may be necessary for stone removal. Anatrophic nephrolithotomy is based on the blood supply to the kidney, using the relatively avascular plane of Brodels line for the lateral renal parenchymal incision prior to entering the collecting system. This approach permits wide exposure of the renal pelvis enabling en bloc removal of the branched calculi with minimal residual calculi [Blandy and Singh, 1976]. Patients with complex stones or evidence of parenchymal loss may benefit from either partial or complete nephrectomy for stone disease [Assimos, Boyce, Harrison, et al., 1989].
C. 5
Index
(Entries followed by f indicate figures; entries followed by t indicate tables.)
A
Anatrophic nephrolithotomy . . . . . . . . . . . . . . . . .9-10 Anesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2, 19
F
FAST*PRO meta-analysis package . . . . . . . . . . . .5-7 Fluoroscopy, stone localization . . . . . . . . . . . . . . .C.2
B
Balance sheet, outcome analysis of treatment alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13t Blood transfusion, comparison of modalities . . . . .16, 16f
G
Guideline, as treatment policy recommendation . .2-5, 20
H
Health care resources, share of . . . . . . . . . . . . . . .5 Hospitalization, all treatment modalities . . . . . . . .18 Hydronephrosis . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Hydrothorax . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
C
Calcium oxalate monohydrate, in staghorn calculi .1, 9 Calcium, in staghorn calculi . . . . . . . . . . . . . . . . .1, 9 Collecting system . . . . . . . . . . . . . . . . . . . . . . . . .1, 9 Combination therapy . . . . . . . . . . . . . . . . . . . . . . .1, 2, 3, 4, 11, 19, 20 acute complications . . . . . . . . . . . . . . . . . . . . . .14-15 blood transfusion required . . . . . . . . . . . . . . . . .2, 19 description . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 hospital days . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 long-term complications . . . . . . . . . . . . . . . . . . .17-18 management of staghorn calculi and . . . . . . . . . .11 outcome analysis of treatment alternatives . . . . .13t procedures per patient . . . . . . . . . . . . . . . . . . . . .16 residual fragments after . . . . . . . . . . . . . . . . . . .2, 19 stone-free rate . . . . . . . . . . . . . . . . . . . . . . . . . . .14 treatment recommendations . . . . . . . . . . . . . . . .3, 20-21 Complications acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-17 combination therapy . . . . . . . . . . . . . . . . . . . . .15 comparison of modalities . . . . . . . . . . . . . . . . .16f open surgery . . . . . . . . . . . . . . . . . . . . . . . . . .15 outcomes of different treatments . . . . . . . . . . .13t percutaneous nephrolithotomy . . . . . . . . . . . . .15 shock-wave lithotripsy . . . . . . . . . . . . . . . . . . .15 treatment recommendations and . . . . . . . . . . . .17 long-term . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-18 combination therapy . . . . . . . . . . . . . . . . . . . . .17-18 open surgery . . . . . . . . . . . . . . . . . . . . . . . . . .17-18 outcomes of different treatments . . . . . . . . . . .13t percutaneous nephrolithotomy . . . . . . . . . . . . .17-18 shock-wave lithotripsy . . . . . . . . . . . . . . . . . . .17-18 treatment recommendations and . . . . . . . . . . . .17 Confidence profile method . . . . . . . . . . . . . . . . . .6-7, 7f Cystine, in staghorn calculi . . . . . . . . . . . . . . . . . .1, 9
I
Infected stones . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 9
K
Kidney, loss of . . . . . . . . . . . . . . . . . . . . . . . . . . .14, 17, 18f
L Archived Document For Reference Only
Laser, lithotripsy . . . . . . . . . . . . . . . . . . . . . . . . . .C.4 Limitations in the literature . . . . . . . . . . . . . . . . . .4, 8, 21 Literature search . . . . . . . . . . . . . . . . . . . . . . . . . .5-6 Lithotripter instrumentation . . . . . . . . . . . . . . . . . .C.1-C.32 dual imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.2 variable power . . . . . . . . . . . . . . . . . . . . . . . . . .C.3 Lithotripsy electrohydraulic . . . . . . . . . . . . . . . . . . . . . . . . .C.4 laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.4 shock-wave; see shock-wave lithotripsy ultrasonic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.3-C.4
M
Magnesium ammonium phosphate; see struvite MEDLINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
N
Nephrectomy . . . . . . . . . . . . . . . . . . . . . . . . . . . .3, 9, 10, 21 Nephrolithiasis Clinical Guidelines Panel, AUA . .1-5, A8A10 Nephrolithotomy; see percutaneous nephrolithotomy Nephroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-14, C.3 Nephrostomy tract . . . . . . . . . . . . . . . . . . . . . . . . .C.3 Nephrostomy tube placement . . . . . . . . . . . . . . . .16 Nephrotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
D
Death, comparison of modalities . . . . . . . . . . . . . .15, 16f Diasonics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.1 Dornier HM-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 14, C.1 Dual imaging, stone localization . . . . . . . . . . . . . .C.2
E
EDAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14, C.1 Electrohydraulic devices . . . . . . . . . . . . . . . . . . . .C.1 Extracorporeal shock-wave lithotripsy; see shock-wave lithotripsy Explicit approach, development of practice policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
O
Obesity, open lithotomy and . . . . . . . . . . . . . . . . .C.5 Open surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4, C.5 acute complications . . . . . . . . . . . . . . . . . . . . . .14-15 blood transfusion required . . . . . . . . . . . . . . . . .2, 19 description . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 10, C.5 hospital days . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 long-term complications . . . . . . . . . . . . . . . . . . .17-18
I. 1
management of staghorn calculi and . . . . . . . . . .9-10 outcome analysis of treatment alternatives . . . . .13t procedures per patient . . . . . . . . . . . . . . . . . . . . .16 residual fragments after . . . . . . . . . . . . . . . . . . .2, 19 stone-free rate . . . . . . . . . . . . . . . . . . . . . . . . . . .14 treatment recommendations . . . . . . . . . . . . . . . .3, 21 Option, as treatment policy recommendation . . . . .2, 3, 4, 5, 21 Outcome analysis, staghorn treatment alternatives .12-18 Outcomes complications with primary treatment . . . . . . . . .2, 14-16, 19 direct and indirect . . . . . . . . . . . . . . . . . . . . . . . .12 secondary, unplanned procedures . . . . . . . . . . . .2, 19 stone-free rate . . . . . . . . . . . . . . . . . . . . . . . . . . .2, 13-14, 19
P
Panendoscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.3 Papyrus Bibliography System . . . . . . . . . . . . . . . .6, A1-A3 PARADOX database . . . . . . . . . . . . . . . . . . . . . . .6 Partial staghorn . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 9 Patient circumstances, choice of treatment modality and . . . . . . . . . . . . . . . . . . . . . . . . . . . .2, 19 Patients, standard and nonstandard . . . . . . . . . . . .2, 4, 1920 Pelviolithotomy . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Percutaneous nephrolithotomy . . . . . . . . . . . . . . .1, 2, 3, 4, 10, 19, 20-21 acute complications . . . . . . . . . . . . . . . . . . . . . .14-15 blood transfusion required . . . . . . . . . . . . . . . . .2, 19 description . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, C.3 hospital days . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 long-term complications . . . . . . . . . . . . . . . . . . .17-18 management of staghorn calculi and . . . . . . . . . .10 outcome analysis of treatment alternatives . . . . .13t procedures per patient . . . . . . . . . . . . . . . . . . . . .16 residual fragments after . . . . . . . . . . . . . . . . . . .2, 19 stone-free rate . . . . . . . . . . . . . . . . . . . . . . . . . . .14 techniques in stone manipulation . . . . . . . . . . . .C.3 treatment recommendations . . . . . . . . . . . . . . . .3, 20-21 Percutaneous nephrostomy, tube placement . . . . . .11 Piezoelectric devices . . . . . . . . . . . . . . . . . . . . . . .14, C.1 Pneumothorax . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Practice policies, development of . . . . . . . . . . . . .5 Primary procedures . . . . . . . . . . . . . . . . . . . . . . . .16-17 Pyelonephritis, acute . . . . . . . . . . . . . . . . . . . . . . .10 Pyelotomy, extended . . . . . . . . . . . . . . . . . . . . . . .9

T
Shock-wave lithotripsy . . . . . . . . . . . . . . . . . . . . .1, 2, 3, 4, 10-11, 19, 20-21 acute complications . . . . . . . . . . . . . . . . . . . . . .14-15 blood transfusion required . . . . . . . . . . . . . . . . .2, 19 description . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 11, C.1 hospital days . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 long-term complications . . . . . . . . . . . . . . . . . . .17-18 management of staghorn calculi and . . . . . . . . . .10-11 outcome analysis of treatment alternatives . . . . .13t procedures per patient . . . . . . . . . . . . . . . . . . . . .16 residual fragments after . . . . . . . . . . . . . . . . . . .2, 19 stone-free rate . . . . . . . . . . . . . . . . . . . . . . . . . . .14 treatment recommendations . . . . . . . . . . . . . . . .3, 20-21 unplanned secondary procedures after . . . . . . . . .2, , 19 Siemans Lithostar . . . . . . . . . . . . . . . . . . . . . . . . .14, C.2 Sonotrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.3 Staghorn calculi background . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 basic research needs . . . . . . . . . . . . . . . . . . . . . .21-22 definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 9 development of treatment recommendations . . . .1-4 outcome analysis of treatment alternatives . . . . .12-18 radiologic appearance . . . . . . . . . . . . . . . . . . . . .1, 9 size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 9 treatment modalities . . . . . . . . . . . . . . . . . . . . . .1-4 treatment recommendations . . . . . . . . . . . . . . . .3, 20-21 Standard, as treatment policy recommendation . . .2, 3, 4, 5, 20 Stent migration . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Stone growth . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17f Stone recurrence . . . . . . . . . . . . . . . . . . . . . . . . . .17f Stone-free rate . . . . . . . . . . . . . . . . . . . . . . . . . . . .2, 19 outcomes of different treatments . . . . . . . . . . . . .13t, 1314, 14f treatment recommendations and . . . . . . . . . . . . .17 Struvite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 9
Tomography, renal, visualization of residual fragments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-14 Treatment recommendations limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 8, 21 outcomes and . . . . . . . . . . . . . . . . . . . . . . . . . . .19 standard and nonstandard patients . . . . . . . . . . . .19-20 standards, guidelines, and options . . . . . . . . . . . .3, 20-21
R
Radiography, visualization of residual fragments . .13-14 Random-effects model . . . . . . . . . . . . . . . . . . . . .6-8 Renacidin, irrigation with . . . . . . . . . . . . . . . . . . .11 Renal pelvis perforation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 staghorn calculi in . . . . . . . . . . . . . . . . . . . . . . .1, 9 Research needs . . . . . . . . . . . . . . . . . . . . . . . . . . .21
U
Ultrasonic lithotripsy . . . . . . . . . . . . . . . . . . . . . . .C.3 Ultrasonography lithotripsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.3 residual fragment visualization . . . . . . . . . . . . . .13-14 stone localization . . . . . . . . . . . . . . . . . . . . . . . .C.2 Urease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 9 Ureteroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, C.4 Uric acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 9 Urinary tract infection, struvite staghorn calculi . .1, 9 Urinoma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
S
Secondary procedures . . . . . . . . . . . . . . . . . . . . . .2, 16-17, 19 unplanned . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2, 14, 19 Sepsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Shock waves coupling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.2 focusing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.2 generation of . . . . . . . . . . . . . . . . . . . . . . . . . . .C.1 localization . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C.2
W
Watchful waiting . . . . . . . . . . . . . . . . . . . . . . . . . .2, 3, 20 Wolf 2300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14, C.1 Wolf Piezolith 2500 . . . . . . . . . . . . . . . . . . . . . . .C.2
I. 2
American Urological Association, Inc.

Board of Directors (1993 - 1994)
Abraham T.K. Cockett, MD* C. Eugene Carlton, Jr., MD* H. Logan Holtgrewe, MD* William R. Turner, Jr., MD* Roy J. Correa, Jr., MD* Harry C. Miller, Jr., MD* Dennis J. Card, MD* E. Darracott Vaughan, Jr., MD* John D. Silbar, MD* Irwin N. Frank, MD* Winston K. Mebust, MD* W. Lamar Weems, MD* Jack W. McAninch, MD* Harry E. Lichtwardt, MD Jay Y. Gillenwater, MD Joseph N. Corriere, Jr., MD Alan H. Bennett, MD G. James Gallagher Richard J. Hannigan *Voting
Practice Parameters, Standards and Guidelines Committee (1993 - 1994)

Winston K. Mebust, MD, Chair John D. McConnell, MD, Vice-Chair Anton J. Bueschen, MD Abraham T. K. Cockett, MD Roy J. Correa, Jr., MD Thomas C. Fenter, MD John B. Forrest, MD John A. Fracchia, MD Charles E. Hawtrey, MD John A. Heaney, MD Warren W. Koontz, Jr., MD Richard G. Middleton, MD Harry C. Miller, Jr., MD Ian M. Thompson, Jr., MD William R. Turner, Jr., MD Hanan Bell, PhD, Consultant Alfred S. Buck, MD, Consultant Claus G. Roehrborn, MD, Consultant Linda D. Shortliffe, MD, Consultant Edward S. Tank, Jr., MD, Consultant
Archived Document Health Policy Department Staff and Consultants For Reference Only
1120 N. Charles Street Baltimore, MD 21201 Phone: 410.727.1100 Fax: 410.223.4375 Stephanie Mensh Director Kim Hagedorn Assistant to Director Sheri Huff Secretary Lisa Emmons Health Policy Manager Tracy Kiely Health Policy Information Assistant Betty Roberts Administrative Assistant Megan Cohen Government Relations Coordinator Roger Woods Government Relations Assistant Randolph B. Fenninger Washington Liaison Justine Germann Legislative Associate William Glitz Public Relations Consultant
Harriet Rubinson Practice Quality Coordinator Julie Bowers Administrative Assistant
Karen Costanzo University of Texas, Southwestern Medical School
This Report on the Management of Staghorn Calculi was developed by the Nephrolithiasis Clinical Guidelines Panel of the American Urological Association, Inc. This Report is intended to furnish to the skilled practitioner a consensus of clear principles and strategies for quality patient care, based on current professional literature, clinical experience, and expert opinion. It does not establish a fixed set of rules or define the legal standard of care, preempting physician judgement in individual cases. An attempt has been made to recommend a range of generally acceptable modalities of treatment, taking into account variations in resources and in patient needs and preferences. It is recommended that the practitioner articulate and document the basis for any significant deviation from these parameters. Finally, it is recognized that conformance with these guidelines cannot ensure a successful result. The parameters should not stifle innovation, but will, themselves, be updated and will change with both scientific knowledge and technological advances.
Report on the Management of Staghorn Calculi
American Urological Association, Inc. 1000 Corporate Boulevard Linthicum, Maryland 21090
September 1994

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American Urological Association, Inc.

Nephrolithiasis Clinical Guidelines Panel:

Report on the Management of Staghorn Calculi

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Clinical Practice Guidelines

Nephrolithiasis Clinical Guidelines Panel Members and Consultants

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Executive Summary: Treatment of staghorn calculi

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OUTCOMES AND ALTERNATIVE MODALITIES

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SELECTION AND DATA EXTRACTION

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Median .746 .750 .667 .716

95% CI .536 - .898 .722 - .776 .628 - .703 .687 - .743

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Chapter 2: Staghorn calculi and their management

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Percutaneous stone removal

Extracorporeal shock-wave lithotripsy

Combination PNL and SWL

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Chapter 3: Outcomes analysis for staghorn treatment alternatives

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ANALYSIS OF THE BALANCE SHEET OUTCOMES

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Figure 4. Staghorn stone-free rates

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Procedures per patient (primary and secondary)

Figure 5. Overall significant complications: Comparison of modalities

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Figure 6. Transfusions: Comparison of modalities

Figure 7. Death: Comparison of modalities

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Figure 8. Stone recurrence: All modalities combined

Figure 9. Stone growth: All modalities combined

Figure 10. Loss of kidney: All modalities combined

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Chapter 4: Staghorn treatment recommendations

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