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STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy
Sponsor: Brigham and Women's Hospital
Summary
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches.
Official title: STENT X Non-stent Genito-urinary Tract Reconstruction After Radical Cystectomy for Bladder Cancer - a Prospective, Randomized, Controlled and Multi Institutional Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2026-09-01
Completion Date
2029-08-31
Last Updated
2026-06-17
Healthy Volunteers
No
Interventions
ureteral stents
standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy
no ureteral stent
no ureteral stents used at time of radical cystectomy
Locations (2)
Brigham and Women's Hospital
Boston, Massachusetts, United States
Instituto do Câncer do Estado de São Paulo (ICESP)
São Paulo, São Paulo, Brazil