Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Individuals must meet all the following inclusion criteria to be eligible to participate in the study:
‣ Provide signed and dated informed consent form
⁃ Willing to comply with all study procedures and be available for the duration of the study
⁃ Male or female, age 18 to 85
⁃ Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion
Locations
United States
Pennsylvania
Jefferson Einstein Philadelphia Hospital
NOT_YET_RECRUITING
Philadelphia
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Mihir S Shah, MD
Mihir.Shah@jefferson.edu
215-955-6961
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 70
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Thomas Jefferson University