Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer

No AccessJournal of UrologyAdult Urology1 Aug 2015Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer Eila C. Skinner, Adrian S. Fairey, Susan Groshen, Siamak Daneshmand, Jie Cai, Gus Miranda, and Donald G. Skinner Eila C. SkinnerEila C. Skinner Department of Urology, Stanford University, Stanford, California , Adrian S. FaireyAdrian S. Fairey Department of Urology, University of Alberta, Edmonton, Canada , Susan GroshenSusan Groshen USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California , Siamak DaneshmandSiamak Daneshmand USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California , Jie CaiJie Cai USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California , Gus MirandaGus Miranda USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California , and Donald G. SkinnerDonald G. Skinner USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California View All Author Informationhttps://doi.org/10.1016/j.juro.2015.03.101AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: The need to prevent reflux in the construction of an orthotopic ileal neobladder is controversial. We designed the USC-STAR trial to determine whether the T-pouch neobladder that included an antireflux mechanism was superior to the Studer pouch in patients with bladder cancer undergoing radical cystectomy. Materials and Methods: This single center, randomized, controlled trial recruited patients with clinically nonmetastatic bladder cancer scheduled to undergo radical cystectomy with neobladder. Eligible patients were randomly assigned to undergo T-pouch or Studer ileal orthotopic neobladder. Treatment assignment was not masked. The primary end point was change in renal function from baseline to 3 years. The CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation was used to calculate the estimated glomerular filtration rate. Results: Between February 2002 and November 2009, 237 patients were randomly assigned to T-pouch ileal orthotopic neobladder and 247 to Studer ileal orthotopic neobladder. Baseline characteristics did not differ between the groups. Between baseline and 3 years the estimated glomerular filtration rate decreased by 6.4 ml/minute/1.73 m2 in the Studer group and 6.6 ml/minute/1.73 m2 in the T-pouch group (p=0.35). Multivariable analysis showed that type of ileal orthotopic neobladder was not independently associated with 3-year renal function (p=0.63). However, baseline estimated glomerular filtration rate, age and urinary tract obstruction were independently associated with 3-year decline in renal function. Cumulative risk of urinary tract infection and overall late complications were not different between the groups, but the T-pouch was associated with an increased risk of secondary diversion related surgeries. Conclusions: T-pouch ileal orthotopic neobladder with an antireflux mechanism did not prevent a moderate reduction in renal function observed at 3 years compared to the Studer pouch, but did result in an increase in diversion related secondary surgical procedures. References 1 : Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol2001; 19: 666. Crossref, Medline, Google Scholar 2 : Long-term complications of conduit urinary diversion. J Urol2011; 185: 562. Link, Google Scholar 3 : Renal function up to 16 years after conduit (refluxing or anti-reflux anastomosis) or continent urinary diversion. 2. Renal scarring and location of bacteriuria. Br J Urol1995; 76: 546. Crossref, Medline, Google Scholar 4 : Changes in the upper urinary tract after radical cystectomy and urinary diversion: a comparison of antirefluxing and refluxing orthotopic bladder substitutes and ileal conduit. J Urol2006; 175: 185. Link, Google Scholar 5 : Refluxing chimney versus nonrefluxing Le Duc ureteroileal anastomosis for orthotopic ileal neobladder: a comparative analysis for patients with bladder cancer. J Urol2006; 175: 1389. Link, Google Scholar 6 : Complications of the afferent antireflux valve mechanism in the Kock ileal reservoir. J Urol1996; 155: 1579. Link, Google Scholar 7 : A randomized study comparing an antireflux system with a direct ureteric anastomosis in patients with orthotopic ileal neobladders. BJU Int2006; 97: 1057. Google Scholar 8 : Surgical atlas: radical cystectomy. BJU Int2004; 84: 197. Google Scholar 9 : Lymph node dissection technique is more important that lymph node count in identifying nodal metastases in radical cystectomy patients: a comparative mapping study. Eur Urol2011; 60: 946. Google Scholar 10 : Three years' experience with an ileal low pressure bladder substitute. Br J Urol1989; 63: 43. Crossref, Medline, Google Scholar 11 : Surgical atlas: the orthotopic T-pouch ileal neobladder. BJU Int2006; 98: 469. Google Scholar 12 : Replacement of the bladder by the urethral Kock pouch: functional results, urodynamics and radiological features. J Urol1989; 141: 1111. Link, Google Scholar 13 : Comparison of risk prediction using the CKD-EPI equation and the MDRD study equation for estimated glomerular filtration rate. JAMA2012; 307: 1941. Google Scholar 14 : Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg2004; 240: 205. Google Scholar 15 : Long-term renal function outcomes after radical cystectomy. J Urol2014; 191: 619. Link, Google Scholar 16 : 25 Years of experience with 1,000 neobladders: long-term complications. J Urol2011; 185: 2207. Link, Google Scholar © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byHautmann R, de Petriconi R, Kahlmeyer A, Enders M and Volkmer B (2017) Preoperatively Dilated Ureters are a Specific Risk Factor for the Development of Ureteroenteric Strictures after Open Radical Cystectomy and Ileal NeobladderJournal of Urology, VOL. 198, NO. 5, (1098-1106), Online publication date: 1-Nov-2017. Volume 194 Issue 2 August 2015 Page: 433-440 Supplementary Materials Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.Keywordsurinary diversioncystectomyMetrics Author Information Eila C. Skinner Department of Urology, Stanford University, Stanford, California More articles by this author Adrian S. Fairey Department of Urology, University of Alberta, Edmonton, Canada More articles by this author Susan Groshen USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Siamak Daneshmand USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Jie Cai USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Gus Miranda USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Donald G. Skinner USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Expand All Advertisement PDF downloadLoading ...