NCT03718754

En-bloc vs Conventional Resection of Primary Bladder Tumor

En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: David D'Andrea · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DEVICE	En-Bloc TURB	En-bloc resection will be performed at each center based on local clinical practice and available instruments. Laser resection, hydrodissection with HybridKnife® or electric resection are allowed. All procedures, including cTURB, must be performed with an imaging enhancing technique (PDD / NBI at surgeon's discretion). After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.
DEVICE	Conventional TURB	En-bloc resection will be performed at each center based on local clinical practice and available instruments. After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.

Timeline

• Start date: 2019-02-28
• Primary completion: 2021-01-20
• Completion: 2021-01-20
• First posted: 2018-10-24
• Last updated: 2023-03-16

Locations

1 site across 1 country: Austria