60 Participants Needed

Early vs Late Stent Removal for Bladder Cancer

(STENT-OPT Trial)

KC
Overseen ByKaydee Connors, BSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Western University, Canada
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Able to give informed written consent to participate
I am an adult with bladder cancer scheduled for major bladder surgery.

Exclusion Criteria

I am undergoing or have undergone a specific type of urinary tract surgery.
I have had radiotherapy in my abdomen or pelvis before.
My treatment is not aimed at curing my condition.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radical cystectomy and ileal conduit formation with either early stent removal (5-7 days) or late stent removal (4-6 weeks)

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of uretero-enteric anastomosis complications

1 year

Treatment Details

Interventions

  • Early Stent removal
  • Late Stent removal
Trial Overview The study tests the timing of stent removal following bladder cancer surgery with an ileal conduit urinary diversion. Participants will be randomly assigned to have their stents removed either early or late post-operation, aiming to determine which method leads to fewer complications like infections or strictures.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment1 Intervention
Early Stent removal
Group II: Arm BActive Control1 Intervention
Late Stent removal

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials
270
Recruited
62,500+

References

Tolerance of radiotherapy and chemotherapy in elderly patients with bladder cancer. [2019]
Management of muscle-invasive bladder cancer in the elderly. [2007]
[Surgical treatment of advanced baldder carcinoma]. [2017]
Radical cystectomy in the elderly patient. [2019]
Radical cystectomy for invasive bladder cancer in the octogenarian. [2022]
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