RecruitingNCT05969964

Can Second Resection for pT1 Bladder Cancer be Avoided After Initial En-Bloc Resection With Negative Safety Margins

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

Sponsor

Mansoura University

Enrollment

370 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

Bladder Cancer Stage I

Summary

The goal of this \[ Can second resection for pT1 bladder carcinoma be safely avoided after initial En-Bloc Resection with negative vertical and horizontal safety margins ? is to assess the impact of avoiding re TUR on Recurrence free survival, progression free survival and cancer specific survival in patients with pT1 bladder cancer treated with ERBT and intravesical BCG through a RCT.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria1

• Patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology.

Exclusion Criteria5

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.

Interventions

BEHAVIORALAvoid second resection after initial complete resection

Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines.

Locations(1)

Urology and nephrology center, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

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NCT05969964