En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- David D'Andrea
- Enrollment
- 384
- Locations
- 1
- Primary Endpoint
- The pathological staging assessment for eTURB compared to cTURB
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Based on current evidence, we hypothesize that eTURB represents an improvement in the surgical management of NMIBC. The resection is more precise and complete compared to cTURB. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy.
To answer these questions, we designed a RCT comparing eTURB with cTURB. Primary outcome of our study will be the accuracy of pathological staging assessment measured by the presence of detrusor muscle in the specimen as a surrogate parameter for quality of resection.
Investigators
David D'Andrea
M.D.
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The pathological staging assessment for eTURB compared to cTURB
Time Frame: 4 weeks
The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB
Secondary Outcomes
- Residual disease within 3 months after initial TURB(3 months)
- Recurrence-free survival(up to 5 years)
- Occurrence of obturator reflex(1 day)
- Number of participants with obturator reflex(1 day)
- Number of tumors with positive lateral and deep resection margin(4 weeks)
- Operative time(1 day)
- Number of participants with bladder perforation(7 days)
- Upstaging of disease upon second look transurethral resection surgery(6 weeks)
- Number of tumors with evaluable lateral and deep resection margin(4 weeks)
- Number of participants with conversion to other resection technique(1 day)
- Number of participants with persistent disease at 2nd look TURB(6 weeks)