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

NCT ID: NCT06595446

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2026-10-01

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

Study Design

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

Study Groups

Arm A

Early Stent removal

Group Type: EXPERIMENTAL

Early Stent removal

Intervention Type: PROCEDURE

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

Arm B

Late Stent removal

Group Type: ACTIVE_COMPARATOR

Late Stent removal

Intervention Type: PROCEDURE

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

Interventions

Early Stent removal

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

Intervention Type: PROCEDURE

Late Stent removal

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

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

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Power

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Victoria Hospital

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kaydee Connors, BSc

Role: CONTACT

kaydee.connors@lhsc.on.ca

519-685-8500 ext. 56366

Facility Contacts

Kaydee Connors, BsC

Role: primary

519-685-8500 ext. 56366

References

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.

Reference Type: BACKGROUND

PMID: 32303901 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34416355 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33938798 (View on PubMed)

Other Identifiers

125609

Identifier Type: -

Identifier Source: org_study_id