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NOT YET RECRUITING
NCT07655284
PHASE3

STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

DEVICE

ureteral stents

standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy

DEVICE

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