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Trial Title:
A Feasibility Randomized Trial Evaluating Early Vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer
NCT ID:
NCT06595446
Condition:
Bladder Cancer Requiring Cystectomy
Ileal Conduit
Urinary Diversion
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Bladder cancer
Radical cystectomy
Stent dwell time
Complications
Ileal conduit
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Early Stent removal
Description:
Ureteral JJ stents removed 5-7 days after radical cystectomy and ileal conduit formation
Arm group label:
Arm A
Intervention type:
Procedure
Intervention name:
Late Stent removal
Description:
Ureteral JJ stents removed 4-6 weeks after radical cystectomy and ileal conduit formation
Arm group label:
Arm B
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Victoria Hospital
Address:
City:
London
Country:
Canada
Contact:
Last name:
Kaydee Connors, BsC
Phone:
519-685-8500
Phone ext:
56366
Email:
kaydee.connors@lhsc.on.ca
Start date:
October 1, 2024
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Western University, Canada
Agency class:
Other
Source:
Western University, Canada
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06595446
