NCT05223491

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Jørgen Bjerggaard Jensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty. Background: NMIBC is a common disease with a 5-year recurrence rate reported as high as 64%. The cornerstone in the treatment of NMIBC is transurethral resection (TURB) where the tumour is dissected in pieces, removed from the bladder, and pathologically examined for potential muscle invasion. As the tumour is fragmented before removal, the method violates basic oncological principles and compromises pathological examination. Hence, TURB is possibly part of the mechanism causing recurrences. En Bloc resection (EBR), where the tumour is removed in toto, can potentially overcome the flaws of conventional TURB, but large randomized trials are needed. Methods: This project will be a multicentre randomised controlled clinical trial comparing EBR to conventional TURB. Patients with suspected NMIBC tumours with largest tumour diameter ≥1cm and ≤6cm will be randomised to either the intervention group, thus undergoing EBR, or the control group, undergoing conventional TURB. The investigators intend to include 220 patients in total, 110 patients in each group. The RCT will be initiated in 2022. Perspectives: If EBR can be shown to remove bladder tumours with better pathological quality and certainty, this could potentially spare patients from undergoing surgeries in the future, thereby reducing costs for both patients and society.

Conditions

• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	En Bloc resection	Tumour is resected and removed from the bladder in one piece, if possible.
PROCEDURE	Conventional TURB	Tumour is resected piecemeal.

Timeline

• Start date: 2022-03-17
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2022-02-04
• Last updated: 2026-01-16

Locations

11 sites across 5 countries: Denmark, Estonia, Finland, Latvia, Norway