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

Starting soon · Phase 3

Conditions studied: Bladder Cancer Requiring Cystectomy, Ureteral Stents

In brief

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.

Key facts

Study ID

NCT07655284

Run by

Brigham and Women's Hospital

People needed

190

Starts

2026-09-01

Expected to finish

2029-08-31

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (> 18 years old)
• Muscle invasive bladder cancer or non-muscle invasive bladder cancer with indication of Radical Cystectomy
• No concomitant surgeries like nephrectomies, colectomies or removal of other organs affected by the tumor (Except standard lymph node dissections as well as in men the prostate and seminal vesicles and in women the uterus, fallopian tubes, ovaries and vagina, that are considered part of the oncological radical cystectomy.)
• Patients who have the capacity to understand the study procedures and provide written informed consent

You may not qualify if…

• Simultaneous surgical procedures (except those specified in the inclusion criteria that are considered part of a routine radical cystectomy)
• History of prior urinary diversion
• Patients who decline to participate, lack understanding of the study's purpose, or are unable to provide informed consent
• Cystectomy for other reasons than Bladder cancer
• Previous radiation therapy in the pelvis for any reason
• Extremely debilitated patients, malnourished individuals, or those undergoing palliative or hygienic cystectomy

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Instituto do Câncer do Estado de São Paulo (ICESP) — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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