En-bloc vs Conventional Resection of Primary Bladder Tumor

Phase 3

Completed

• Conditions: Bladder Cancer
• Interventions: Device: En-Bloc TURB; Device: Conventional TURB

• Registration Number: NCT03718754
• Lead Sponsor: David D'Andrea

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Study Start: 2019-02-28
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
En-Bloc TURB	En-Bloc TURB	-
Conventional TURB	Conventional TURB	-

Primary Outcome Measures

Name	Time	Method
The pathological staging assessment for eTURB compared to cTURB	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 Outcome Measures

Name	Time	Method
Occurrence of obturator reflex	1 day
Residual disease within 3 months after initial TURB	3 months
Recurrence-free survival	up to 5 years
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria