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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07655284
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Bladder Cancer Requiring Cystectomy
  • Ureteral Stents

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ureteral stents — DEVICE
    standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy
  • no ureteral stent — DEVICE
    no ureteral stents used at time of radical cystectomy

Study Details

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 Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ureteral stents placed at time of cystectomy
    standard of care ureteral stent placement at time of radical cystectomy (control arm)
  • Experimental: stent-free, no stent placement at time of cystectomy
    forgo ureteral stent placement at time of radical cystectomy (intervention arm)

Primary Outcome Measure

Post-operative readmission rate [ Time Frame: 30-days after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Timothy N Clinton, MD
[email protected]
617-732-6384

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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