Early vs Late Stent Removal for Bladder Cancer
(STENT-OPT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does early vs late stent removal for bladder cancer differ from other treatments?
The early vs late stent removal treatment for bladder cancer is unique because it focuses on the timing of stent removal, which is a device used to keep the urinary tract open, rather than on traditional methods like surgery, chemotherapy, or radiotherapy. This approach may offer a different way to manage complications related to stent placement in bladder cancer patients.12345
What is the purpose of this trial?
Bladder cancer is the 4th most common cancer in men and 5th most common type of cancer in Canada. Urothelial cancer accounts for approximately 90% of malignancies. At diagnosis, over 75% of cases are classified as non-muscle invasive (NMIBC), and with appropriate treatment, the majority of these patients achieve positive outcomes. The progression rate of NMIBC to Muscle-invasive bladder cancer (MIBC) varies between 5-50% at 5 years dependent on histopathological features such as grade, stage, presence of CIS and age (Carcinoma in Situ). The optimal treatment of MIBC (T2-T4N0M0) consists of neoadjuvant cisplatin-based chemotherapy followed by Radical cystectomy and urinary diversion (RCUD). In the last couple of decades, RCUD has also gained attention for treating patients with high-risk non-muscle invasive bladder cancer. Despite advancements in surgical techniques and the rise of minimally invasive alternatives, complications after surgery remain frequent, with morbidity rates of approximately 50%.Several uncertainties persist in surgical practice, including the role of perioperative ureteric stenting during RCUD. Perioperative ureteric stenting is intended to minimize urinary leakage from the newly created uretero-enteric anastomosis and to prevent early obstruction caused by anastomotic swelling. However, stenting may increase the risk of urinary tract infections (UTIs) and necessitate additional follow-up for stent removal. Peng et al. conducted the most recent systematic review in 2021, demonstrating that ureteral stents in RCUD were linked to higher rates of anastomotic strictures. Their review did not provide evidence that these stents were more effective than not using stents in preventing post-diversion urinary leakage. The review underscored the scarcity of prospective randomized controlled trials examining the safety and effectiveness of stenting in this context. The sole prospective (non-randomized) study assessing stent dwell / retention time after RCUD demonstrated early stent removal (2 weeks) had decreased 90-day readmissions and UTIs.Therefore, the investigators aimed to determine the feasibility of conducting a definitive randomized trial to evaluate patients undergoing radical cystectomy and ileal conduit formation to receive either early stent removal (5-7 days) or late stent removal (4-6 weeks).
Eligibility Criteria
This trial is for individuals who have undergone radical cystectomy and ileal conduit formation due to bladder cancer. It's designed to see if removing stents early (5-7 days) or late (4-6 weeks) after surgery is better. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo radical cystectomy and ileal conduit formation with either early stent removal (5-7 days) or late stent removal (4-6 weeks)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of uretero-enteric anastomosis complications
Treatment Details
Interventions
- Early Stent removal
- Late Stent removal
Find a Clinic Near You
Who Is Running the Clinical Trial?
Western University, Canada
Lead Sponsor