Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07234968
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Ureteral Stent Placement — PROCEDURE
    Placement of ureteral stents (double J or single J) intraoperatively during radical cystectomy with ileal conduit urinary diversion (RCIC). Stent placement will be a one-time occurrence inserted during RCIC, and be removed typically between 7-21 days post-op at the discretion of the surgeon.
  • No Ureteral Stent — PROCEDURE
    Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.
  • Indocyanine Green with Fluorescence Imaging — DIAGNOSTIC_TEST
    Indocyanine green (ICG) with fluorescence imaging is an advanced technique used to enhance the visualization of the ureters during complex pelvic surgeries, such as those for bladder cancer. The technology helps surgeons identify the ureters, which are the tubes connecting the kidneys to the bladder, and distinguish them from surrounding tissues.

Study Details

Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.

Key Dates

Start date
Dec 23, 2025
Status verified
Feb 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: Arm 1: Ureteral Stent
    Subjects randomized to the stent arm will receive ureteral stents (double J or single J ureteral catheter, per surgeon preference) during radical cystectomy with ileal conduit urinary diversion (RCIC). Intraoperative use of indocyanine green with fluorescence imaging with be noted. Ureteral stents will be placed intraoperatively and removed at follow up visit per surgeon discretion. Either approach would be considered standard of care for muscle invasive bladder cancer, for which radical cystectomy with urinary diversion is the gold standard of treatment. They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.
  • Active Comparator: Arm 2: No Ureteral Stent
    Subjects randomized to the no-stent arm will undergo radical cystectomy with ileal conduit urinary diversion (RCIC) without placement of ureteral stents. They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.

Primary Outcome Measure

Number of urinary tract infection (UTI) [ Time Frame: 90 days after surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Jefferson Einstein Philadelphia HospitalPhiladelphiaPennsylvania19141
Mihir S Shah, MD
215-955-6961
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Mihir S Shah, MD
215-955-6961

Find similar trials in Philadelphia, PA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Jefferson Einstein Philadelphia Hospital· Philadelphia, PAThomas Jefferson University Hospital· Philadelphia, PA

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