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

NCT06595446 | Recruiting

• 1 other identifier: 125609
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Bladder Cancer Requiring Cystectomy; Ileal Conduit; Urinary Diversion

Keywords

Bladder cancer; Radical cystectomy; Stent dwell time; Complications; Ileal conduit

Outcome Measures

Primary Outcomes (2)

• Complication rates

  within 30 days:

• Feasibility Outcomes

  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.

  1 year

Secondary Outcomes (3)

• Complication rates

  within 90 days

• Readmission rates

  within 90 days

• Complication rates

  within 1 year

Other Outcomes (1)

• Length of stay

  90 days

Study Arms (2)

Arm A

EXPERIMENTAL

Early Stent removal

Procedure: Early Stent removal

Arm B

ACTIVE COMPARATOR

Late Stent removal

Procedure: Late Stent removal

Interventions

Early Stent removal PROCEDURE

Ureteral JJ stents removed 5-7 days after radical cystectomy and ileal conduit formation

Arm A

Late Stent removal PROCEDURE

Ureteral JJ stents removed 4-6 weeks after radical cystectomy and ileal conduit formation

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Victoria Hospital

London, Ontario, Canada

RECRUITING

Related Publications (3)

• Beano H, He J, Hensel C, Worrilow W, Townsend W, Gaston K, Clark PE, Riggs S. Safety of decreasing ureteral stent duration following radical cystectomy. World J Urol. 2021 Feb;39(2):473-479. doi: 10.1007/s00345-020-03191-2. Epub 2020 Apr 17.

  PMID: 32303901 BACKGROUND

• Peng YL, Ning K, Wu ZS, Li ZY, Deng MH, Xiong LB, Yu CP, Zhang ZL, Liu ZW, Lu HM, Zhou FJ. Ureteral stents cannot decrease the incidence of ureteroileal anastomotic stricture and leakage: A systematic review and meta-analysis. Int J Surg. 2021 Sep;93:106058. doi: 10.1016/j.ijsu.2021.106058. Epub 2021 Aug 18.

  PMID: 34416355 BACKGROUND

• Bhindi B, Kool R, Kulkarni GS, Siemens DR, Aprikian AG, Breau RH, Brimo F, Fairey A, French C, Hanna N, Izawa JI, Lacombe L, McPherson V, Rendon RA, Shayegan B, So AI, Zlotta AR, Black PC, Kassouf W. Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer - Full-text. Can Urol Assoc J. 2021 Aug;15(8):E424-E460. doi: 10.5489/cuaj.7367. No abstract available.

  PMID: 33938798 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Kaydee Connors, BSc

CONTACT

519-685-8500; kaydee.connors@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: November 12, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)