2007 Guideline for the Management of Ureteral Calculi
2007; Lippincott Williams & Wilkins; Volume: 178; Issue: 6 Linguagem: Inglês
10.1016/j.juro.2007.09.107
ISSN1527-3792
AutoresGlenn M. Preminger, Hans‐Göran Tiselius, Dean G. Assimos, P. Alken, Colin Buck, Michele Gallucci, Thomas Knoll, James E. Lingeman, Stephen Y. Nakada, Margaret S. Pearle, Kemal Sarıca, Christian Türk, J. Stuart Wolf,
Tópico(s)Urological Disorders and Treatments
ResumoYou have accessJournal of UrologyAdult urology1 Dec 20072007 Guideline for the Management of Ureteral Calculi Glenn M. Preminger, Hans-Göran Tiselius, Dean G. Assimos, Peter Alken, Colin Buck, Michele Gallucci, Thomas Knoll, James E. Lingeman, Stephen Y. Nakada, Margaret Sue Pearle, Kemal Sarica, Christian Türk, and J. Stuart Wolf Glenn M. PremingerGlenn M. Preminger , Hans-Göran TiseliusHans-Göran Tiselius , Dean G. AssimosDean G. Assimos , Peter AlkenPeter Alken , Colin BuckColin Buck , Michele GallucciMichele Gallucci , Thomas KnollThomas Knoll , James E. LingemanJames E. Lingeman , Stephen Y. NakadaStephen Y. Nakada , Margaret Sue PearleMargaret Sue Pearle , Kemal SaricaKemal Sarica , Christian TürkChristian Türk , and J. Stuart WolfJ. Stuart Wolf View All Author Informationhttps://doi.org/10.1016/j.juro.2007.09.107AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction The American Urological Association Nephrolithiasis Clinical Guideline Panel was established in 1991. Since that time, the Panel has developed three guidelines on the management of nephrolithiasis, the most recent being a 2005 update of the original 1994 Report on the Management of Staghorn Calculi.1 The European Association of Urology began their nephrolithiasis guideline project in 2000, yielding the publication of Guidelines on Urolithiasis, with updates in 2001 and 2006.2 While both documents provide useful recommendations on the management of ureteral calculi, changes in shock-wave lithotripsy technology, endoscope design, intracorporeal lithotripsy techniques, and laparoscopic expertise have burgeoned over the past five to ten years. Under the sage leadership of the late Dr. Joseph W. Segura, the AUA Practice Guidelines Committee suggested to both the AUA and the EAU that they join efforts in developing the first set of internationally endorsed guidelines focusing on the changes introduced in ureteral stone management over the last decade. We therefore dedicate this report to the memory of Dr. Joseph W. Segura whose vision, integrity, and perseverance led to the establishment of the first international guideline project. This joint EAU/AUA Nephrolithiasis Guideline Panel (hereinafter the Panel) performed a systematic review of the English language literature published since 1997 and a comprehensively analyzed outcomes data from the identified studies. Based on their findings, the Panel concluded that when removal becomes necessary, SWL and ureteroscopy remain the two primary treatment modalities for the management of symptomatic ureteral calculi. Other treatments were reviewed, including medical expulsive therapy to facilitate spontaneous stone passage, percutaneous antegrade ureteroscopy, and laparoscopic and open surgical ureterolithotomy. In concurrence with the previously published guidelines of both organizations, open stone surgery is still considered a secondary treatment option. Blind basketing of ureteral calculi is not recommended. In addition, the Panel was able to provide some guidance regarding the management of pediatric patients with ureteral calculi. The Panel recognizes that some of the treatment modalities or procedures recommended in this document require access to modern equipment or presupposes a level of training and expertise not available to practitioners in many clinical centers. Those situations may require physicians and patients to resort to treatment alternatives. This article will be published simultaneously in European Urology and The Journal of Urology®. The Panel believes that future collaboration between the EAU and the AUA will serve to establish other internationally approved guidelines, offering physician and patient guidance worldwide. Methodology The Panel initially discussed the scope of the guideline and the methodology, which would be similar to that used in developing the previous AUA guideline. All treatments commonly employed in the United States and/or Europe were included in this report except for those that were explicitly excluded in the previous guideline or newer treatments for which insufficient literature existed. In the analysis, patient data were stratified by age (adult versus child), stone size, stone location, and stone composition. Later, however, the data were found to be insufficient to allow analysis by composition. The outcomes deemed by the Panel to be of particular interest to the patient included the following: stone-free rate, number of procedures performed, stone-passage rate or probability of spontaneous passage, and complications of treatment. The Panel did not examine economic effects, including treatment costs. Outcomes were stratified by stone location (proximal, mid, and distal ureter) and by stone size (dichotomized as ≤10 mm and >10 mm for surgical interventions, and ≤5 mm and >5 mm for medical interventions and observation where possible; exceptions were made when data were reported, for example as <10 mm and ≥10 mm). The mid ureter is the part of the ureter that overlies the bony pelvis, i.e., the position of the ureter that corresponds to the sacroiliac joint; the proximal ureter is above and the distal ureter is below. Treatments were divided into three broad groups: 1 Observation and medical therapy 2 Shock-wave lithotripsy and ureteroscopy 3 Open surgery, laparoscopic stone removal, or percutaneous antegrade ureteroscopy. The review of the evidence began with a literature search and data extraction. Articles were selected from a database of papers derived from MEDLINE® searches dealing with all forms of urinary tract stones. This database was maintained by a Panel chair. The abstract of each paper was independently reviewed by an American and a European Panel member, and articles were selected for data extraction if any panel member felt it might have useful data. Additional articles were suggested by Panel members or found as references in review articles. In total, 348 citations entered the extraction process. An American and a European Panel member each independently extracted data from each article onto a standardized form. The team members reconciled the extractions, and the data were entered into a Microsoft Access® (Microsoft, Redmond, WA) database. The Panel scrutinized the entries, reconciled the inconsistencies in recording, corrected the extraction errors, and excluded some articles from further analysis for the following reasons: 1 The article was included in the previous guideline. 2 The article did not provide usable data on the outcomes of interest. 3 Results for patients with ureteral stones could not be separated from results for those with renal stones. 4 The treatments used were not current or were not the focus of the analysis. 5 The article was a review article of data reported elsewhere. 6 The article dealt only with salvage therapy. A total of 244 of the 348 articles initially selected had extractable data. Articles excluded from evidence combination remained candidates for discussion in the text of the guideline. The goal was to generate outcomes tables comparing estimates of outcomes across treatment modalities. To generate an outcomes table, estimates of the probabilities and/or magnitudes of the outcomes are required for each intervention. Ideally, these are derived from a synthesis or combination of the evidence. Such a combination can be performed in a variety of ways depending on the nature and quality of the evidence. For this report, the Panel elected to use the Confidence Profile Method,3 which provides methods for analyzing data from studies that are not randomized controlled trials. The Fast*Pro computer software4 was used in the analysis. This program provides posterior distributions from meta-analyses from which the median can be used as a best estimate, and the central 95% of the distribution serves as a confidence interval. Statistical significance at the p 5 mm and ≤10 mm, analysis of three groups (104 patients) yielded an estimate that 47% would pass spontaneously (95% CI: 36% to 59%). Details of the meta-analysis are presented in Appendixes 8 and 9. Two medical therapies had sufficient analyzable data: the calcium channel blocker nifedipine and alpha-receptor antagonists. Analyses of stone-passage rates were done in three ways. The first combined all single arms evaluating the therapies. Using this approach, meta-analysis of four studies of nifedipine (160 patients) yielded an estimate of a 75% passage rate (95% CI: 63% to 84%). Six studies examined alpha blockers (280 patients); the meta-analysis yielded a stone-passage rate of 81% (95% CI: 72% to 88%). The second method was a standard Bayesian hierarchical meta-analysis of the available RCTs that compared either nifedipine or alpha blockers to control therapies. The results for nifedipine showed an absolute increase of 9% in stone-passage rates (95% CI: −7% to 25%), which was not statistically significant. Meta-analysis of alpha blockers versus control showed an absolute increase of 29% in the stone-passage rate (95% CI: 20% to 37%), which was statistically significant. The Panel also attempted to determine whether alpha blockers provide superior stone passage when compared to nifedipine. Two randomized controlled trials were identified. When hierarchical meta-analysis was performed on these two studies, tamsulosin provided an absolute increase in stone-passage rate of 14% (95% CI: −4% to 32%) which was not statistically significant. When nonhierarchical methods were used, the stone-passage improvement increased to 16% (95% CI: 7% to 26%) which was statistically significant. Finally, the Panel used the results of the meta-analyses versus controls (second method above) to determine the difference between alpha blockers and calcium channel blockers. This method allows the use of more data but is risky since it depends on the control groups having comparable results. The analysis yielded a 20% improvement in stone-passage rates with alpha blockers, and the 95% CI of 1% to 37% just reached statistical significance. Shock-wave Lithotripsy and Ureteroscopy Stone-free rates were analyzed for a number of variant methods of performing SWL and URS. The Panel attempted to differentiate between bypass, pushback, and in situ SWL as well as differences between lithotripters. Most differences were minimal and did not reach statistical significance. For that reason, the data presented in this Chapter compare the meta-analysis of all forms of SWL to the meta-analysis of all forms of URS. The Panel also attempted to differentiate between flexible and rigid ureteroscopes. Details of the breakdowns by type of SWL and URS are given in Chapter 3. Data were analyzed for both efficacy and complications. Two efficacy outcomes were analyzed: stone-free rate and procedure counts. Complications were grouped into classes. The most important classes are reported herein. The full complication results are in Appendix 10. Analyses were performed for the following patient groups where data were available. 1 Proximal stones ≤10 mm 2 Proximal stones >10 mm 3 Proximal stones regardless of size 4 Mid-ureteral stones ≤10 mm 5 Mid-ureteral stones >10 mm 6 Mid-ureteral stones regardless of size 7 Distal stones ≤10 mm 8 Distal stones >10 mm 9 Distal stones regardless of size Analyses of pediatric groups were attempted for the same nine groups, although data were lacking for many groups. Efficacy Outcomes Stone-free rates The Panel decided to analyze a single stone-free rate. If the study reported the stone-free rate after all primary procedures, that number was used. If not and the study reported the stone-free rate after the first procedure, then that number was used. The intention of the Panel was to provide an estimate of the number of primary procedures and the stone-free rate after those procedures. There is a lack of uniformity in the literature in reporting the time to stone-free status, thereby limiting the ability to comment on the timing of this parameter. The results of the meta-analysis of stone-free data are presented for the overall group in Table 1 and Figure 1. The results are presented as medians of the posterior distribution (best central estimate) with 95% credible intervals (Bayesian confidence intervals). Table 1. Stone-free rates for SWL and URS in the overall population Overall Population AUA/EAU Ureteral Stones Guideline Panel Stone Free Rate—Primary Treatments or First Treatment SWL URS G/P Med/95% CI G/P Med/95% CI Distal Ureter 50 74% 59 94% 6981 (73–75)% 5952 (93–95)% Distal ureter < 10 mm 17 86% 13 97% 1684 (80–91)% 1622 (96–98)% Distal ureter > 10 mm 10 74% 8 93% 966 (57–87)% 412 (88–96)% Mid Ureter 31 73% 30 86% 1607 (66–79)% 1024 (81–89)% Mid ureter < 10 mm 5 84% 5 91% 44 (65–95)% 80 (81–96)% Mid ureter > 10 mm 2 76% 5 78% 15 (36–97)% 73 (61–90)% Proximal Ureter 41 82% 46 81% 6428 (79–85)% 2242 (77–85)% Proximal ureter < 10 mm 14 90% 9 80% 886 (85–93)% 243 (73–85)% Proximal ureter > 10 mm 11 68% 8 79% 293 (55–79)% 230 (71–87)% G = Number of Groups/Treatment arms extracted; P = Number of Patients in those groups Fig. 1. Stone-free rates for SWL and URS in the overall population. This analysis shows that overall, for stones in the proximal ureter (n = 8,670), there was no difference in stone-free rates between SWL and URS. However, for proximal ureteral stones 10 mm (n = 523), URS had superior stone-free rates. This difference arises because the stone-free rate for proximal ureteral stones treated with URS did not vary significantly with size, whereas the stone-free rate following SWL negatively correlated with stone size. For all distal stones, URS yields better stone-free rates overall and in both size categories. For all mid-ureteral stones, URS appears superior, but the small number of patients may have prevented results from reaching statistical significance. Unfortunately, RCTs comparing these treatments were generally lacking, making an accurate assessment impossible. However, the posterior distributions resulting from the meta-analysis can be subtracted, yielding a distribution for the difference between the treatments. If the CI of this result does not include zero, then the results may be considered to be statistically significantly different. This operation is mathematically justifiable but operationally risky: if the patients receiving different treatments are different or if outcome measures are different, results may be meaningless. Nonetheless, the Panel performed the comparison and found that URS stone-free rates were significantly better than SWL rates for distal ureteral stones ≤10 mm and >10 mm and for proximal ureteral stones >10 mm. The stone-free rate for mid-ureteral stones was not statistically significantly different between URS and SWL. The results with URS using a flexible ureteroscope for proximal ureteral stones appear better than those achieved with a rigid device, but not at a statistically significant level. Stone-free results for pediatric patients are shown in Table 2 and Figure 2. The very small number of patients in most groups, particularly for URS, makes comparisons among treatments difficult. However, it does appear that SWL may be more effective in the pediatric subset than in the overall population, particularly in the mid and lower ureter. Table 2. Stone-free rates for SWL and URS, pediatric population Pediatric Population AUA/EAU Ureteral Stones Guideline Panel Stone Free Rate—Primary Treatments or First Treatment SWL URS G/P Med/95% CI G/P Med/95% CI Distal Ureter 8 80% 9 92% 229 (68–90)% 151 (86–96)% Distal ureter < 10 mm 5 86% 2 86% 135 (78–92)% 29 (72–98)% Distal ureter > 10 mm 2 83% 26 (58–97)% Mid Ureter 6 82% 3 80% 33 (63–94)% 11 (52–96)% Mid ureter < 10 mm 4 80% 16 (41–98)% Mid ureter > 10 mm 1 96% 1 78% 6 (67–100)% 5 (37–99)% Proximal Ureter 7 81% 5 57% 101 (69–90)% 18 (25–85)% Proximal ureter < 10 mm 5 89% 43 (72–98)% Proximal ureter > 10 mm 3 63% 16 (21–94)% G = Number of Groups/Treatment arms extracted; P = Number of Patients in those groups Fig. 2. Stone-free rates for SWL and URS, pediatric population. Procedure Counts Procedure counts were captured as three types: 1 Primary procedures—the number of times the intended procedure was performed. 2 Secondary procedures—the number of times an alternative stone removal procedure(s) was performed. 3 Adjunctive procedures—additional procedures performed at a time other than when the primary or secondary procedures were performed; these could include procedures related to the primary/secondary procedures such as stent removals as well as procedures performed to deal with complications; most adjunctive procedures in the data presented represent stent removals. It is likely that many stent-related adjunctive procedures were underreported, and thus the adjunctive procedure count may be underestimated. As mentioned in Chapter 2, it was not possible to perform a meta-analysis or to test for statistically significant differences between treatments due to the lack of variance data, and only weighted averages could be computed. The procedure count results for the overall population are shown in Table 3 and Figure 3.Figure 3 results are presented as stacked bars. Table 3. Procedure counts for SWL and URS in the overall population Overall Population Procedure Counts Grps/Pts # Procs Grps/Pts # Procs Grps/Pts # Procs Grps/Pts # Procs Grps/Pts # Procs Grps/Pts # Procs SWL URS Primary Secondary Adjunctive Primary Secondary Adjunctive Distal Ureter 48/7117 1.22 30/5069 0.12 15/3875 0.03 56/5308 1.04 25/5124 0.03 24/2848 0.36 Distal ureter < 10 mm 16/1618 1.34 5/170 0.12 12/1117 1.01 6/492 0.05 4/305 0.88 Distal ureter > 10 mm 11/951 1.44 3/1026 0.10 5/231 1.02 1/69 0.14 1/110 1.00 Mid Ureter 10/291 1.11 9/316 0.18 4/241 0.23 25/686 1.04 15/934 0.07 8/357 0.09 Mid ureter < 10 mm 2/31 1.29 4/32 1.00 2/34 0.34 1/7 1.14 Mid ureter > 10 mm 3/53 1.76 2/18 1.00 1/35 0.31 1/5 0.20 Proximal Ureter 37/5902 1.31 20/2131 0.07 13/1329 0.24 42/1634 1.02 27/1831 0.26 14/1159 0.17 Proximal ureter < 10 mm 16/1243 1.26 5/150 0.14 3/114 0.77 6/68 1.00 4/62 0.39 3/27 0.52 Proximal ureter > 10 mm 10/409 1.49 5/83 0.21 4/45 0.56 5/137 1.07 4/130 0.13 1/14 0.21 Fig. 3. Procedure counts for SWL and URS in the overall population. Procedure count results for pediatric patients are shown in Table 4 and Figure 4. Again, the numbers of patients with available data were small and did not support meaningful comparisons among treatments. Table 4. Procedure counts for SWL and URS in the pediatric population, all locations Pediatric Population Procedure Counts SWL URS Grps/Pts # Procs Grps/Pts # Procs Grps/Pts # Procs Grps/Pts # Procs Grps/Pts # Procs Grps/Pts # Procs Primary Secondary Adjunctive Primary Secondary Adjunctive Distal Ureter 7/212 1.38 4/98 0.08 2/43 0.07 10/185 1.05 7/190 0.09 5/96 0.72 Distal ureter < 10 mm 5/135 1.42 1/
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