NCT07234968

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 follow-up visit within 30 days post-operatively, 3 months follow-up visit (+/- 1 week), 6 months follow-up visit (+/- 21 days), and 12 months follow-up visit (+/- 21 days). 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

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	No Ureteral Stent	Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-12-23
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2025-11-19
• Last updated: 2026-02-17

Locations

2 sites across 1 country: United States