A Feasibility Randomized Trial Evaluating Early Vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer

Not Applicable

Not yet recruiting

• Conditions: Bladder Cancer Requiring Cystectomy; Ileal Conduit; Urinary Diversion
• Interventions: Procedure: Early Stent removal; Procedure: Late Stent removal

• Registration Number: NCT06595446
• Lead Sponsor: Western University, Canada

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Submitted: 2024-09-13
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patients (18 years or older) undergoing radical cystectomy and ileal conduit formation for bladder cancer
• Able to give informed written consent to participate.

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Exclusion Criteria

• Treatment without curative intent (cT4b, salvage or palliative cystectomies);
• Patients undergoing alternative forms of urinary diversion (e.g. continent cutaneous urinary diversion or orthotopic neobladder formation)
• Patients previously received abdominal/pelvic radiotherapy
• Patients with concomitant upper urinary tract cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Early Stent removal	Early Stent removal
Arm B	Late Stent removal	Late Stent removal

Primary Outcome Measures

Name	Time	Method
Complication rates	within 30 days:
Feasibility Outcomes	1 year	1. Recruitment Metrics: * Recruitment Rates: Number of participants recruited versus the number of eligible patients.; * Screen Failures: Number of patients screened but found ineligible.; * Non-Consenting Rates: Number of eligible patients who decline participation.; 2. Protocol Adherence: * Randomization Process Success: Rate of successful randomizations without errors.; * Protocol Violations / Deviations: Incidents where clinical needs required deviation from the protocol.; * Completion Rate: Proportion of participants who complete the study according to the protocol.

Secondary Outcome Measures

Name	Time	Method
Complication rates	within 1 year	The secondary outcomes will also include composite Uretero-enteric anastomosis (UEA) complications after radical cystectomy and ileal conduit formation.
Readmission rates	within 90 days

Trial Locations

Locations (1)

Victoria Hospital; 🇨🇦 London, Ontario, Canada