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

NCT ID: NCT07234968

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-04-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ureteral Stent Placement

Intervention Type: 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.

Indocyanine Green with Fluorescence Imaging

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

No Ureteral Stent

Intervention Type: PROCEDURE

Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.

Indocyanine Green with Fluorescence Imaging

Intervention Type: 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.

Interventions

Ureteral Stent Placement

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.

Intervention Type: PROCEDURE

No Ureteral Stent

Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.

Intervention Type: PROCEDURE

Indocyanine Green with Fluorescence Imaging

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

double J; single J; ureteral stents; ICG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mihir S Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Central Contacts

Mihir S Shah, MD

Role: CONTACT

Mihir.Shah@jefferson.edu

215-955-6961

Other Identifiers

JT 45452

Identifier Type: OTHER

Identifier Source: secondary_id

2025-117

Identifier Type: OTHER

Identifier Source: secondary_id

iRISID-2025-0635

Identifier Type: -

Identifier Source: org_study_id