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

Thomas Jefferson University

Status: Not yet enrolling

Conditions: Bladder Cancer; Bladder Neoplasm; Urothelial Carcinoma; Muscle-Invasive Bladder Carcinoma; Pelvic Malignancy; Bladder Transitional Cell Carcinoma

Treatments: Procedure: No Ureteral Stent; Procedure: Ureteral Stent Placement; Diagnostic Test: Indocyanine Green with Fluorescence Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT07234968

2025-117 (Other Identifier)

JT 45452 (Other Identifier)

iRISID-2025-0635

Details and patient eligibility

About

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.

Full description

Patients who are indicated for RCIC will be recruited for this prospective RCT. 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.

Patients will be randomized 1:1 to receive stent or no stent during RCIC (Stent: N=35, No Stent: N=35). Randomization will be stratified by surgical approach (open vs. robotic vs. hybrid). The randomization schedule will be created by the study statistician using the method of random permuted blocks.

Stent placement, if applicable, 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. For this study, subjects will continue to be followed for up to 1-year post-op. Subjects will be enrolled in this study for 12 months.

Post treatment, the patient will have a 2-week follow-up visit (+/- 7 days), 1-month follow-up visit (+/- 7 days), 3-month follow-up visit (+/- 1 week), 6-month follow-up visit (+/- 2 weeks), and 12-month follow-up visit (+/- 2 weeks). Patient will be followed for 12 months post treatment or until their death. Additional visits or follow-ups may be indicated for instances of the need for replacement of ureteral stents and catheters or percutaneous nephrostomies. The need for surgical repair for a ureteral leak or stricture may also occur.

The Principal Investigator hypothesizes that patients with no ureteral stent placement during RCIC will not be associated with a higher risk of post-op complications compared to those with a ureteral stent.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• An individual who meets any of the following criteria will be excluded from participation in this study:

  • Current or history of pelvic radiation
  • Retroperitoneal fibrosis
  • Intraoperative surgeon decision based on patient anatomy (unhealthy appearing ureter or compromised vascular supply to ureter or scarring of the ureter)
  • Untreated urinary tract infection (UTI) within 30 days prior to RCIC
  • Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Arm 1: Ureteral Stent

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Indocyanine Green with Fluorescence Imaging

Procedure: Ureteral Stent Placement

Arm 2: No Ureteral Stent

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Indocyanine Green with Fluorescence Imaging

Procedure: No Ureteral Stent