Avoiding second surgery for early-stage bladder cancer after initial complete resection
Can Second Resection for pT1 Bladder Carcinoma be Safely Avoided After Initial En-Bloc Resection With Negative Vertical and Horizontal Safety Margins: A Randomized Controlled Trial
This study is testing if patients with early-stage bladder cancer can skip a second surgery after their first successful operation and still do well with treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 370 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT05969964 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate whether patients with pT1 bladder cancer can safely avoid a second resection after an initial en-bloc resection with negative safety margins. It will assess the impact of this approach on recurrence-free survival, progression-free survival, and cancer-specific survival in patients treated with intravesical BCG. The study is particularly relevant given the high prevalence of bladder cancer in Egypt and the potential complications associated with repeat surgeries. By focusing on the quality of the initial resection, the study seeks to provide insights into optimizing treatment protocols for non-muscle invasive bladder cancer.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with pT1 bladder cancer who have undergone en-bloc resection with negative safety margins.
Not a fit: Patients with large tumors unsuitable for en-bloc resection, residual tumors, or positive safety margins will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for additional surgeries, minimizing complications and improving patient outcomes.
How similar studies have performed: While some studies have explored the benefits of avoiding repeat resections, this specific approach using en-bloc resection is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology. Exclusion Criteria: * Large tumors not suitable for ERBT * Residual tumor. * Multicentric tumors ( more than 4 lesions) * Presence of CIS. * Positive vertical or horizontal safety margins after initial resection.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Urology and nephrology center, Mansoura University — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Mahmoud Laymon, MD,MRCS — Urology &Nephrology Center, Mansoura University, Egypt
- Study coordinator: Mahmoud Laymon, MD,MRCS
- Email: dr_mahmoudlaymon@mans.edu.eg
- Phone: 01002275698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.