En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    220
  • sponsor
    Jørgen Bjerggaard Jensen
Updated on 3 July 2022

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, is supposed to 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 ≥2cm 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.

Details
Condition Non-muscle Invasive Bladder Cancer
Treatment Conventional TURB, En Bloc Resection
Clinical Study IdentifierNCT05223491
SponsorJørgen Bjerggaard Jensen
Last Modified on3 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Demographics: all BMI, smokers and non-smokers
Primary, papillary, non-solid bladder tumour visualised by flexible cystoscopy
Tumour diameter measured on CT-scan ≥2cm ≤6cm at largest diameter
Ability to fully comprehend the information provided and comply with protocol
Signed consent form
Patients with multiple tumours can be included if it seems feasible to resect them in one procedure

Exclusion Criteria

Clinically suspected muscle invasive bladder cancer (invasion in to bladder muscle or extravesical extension visible on CT or solid tumour without papillary elements seen at cystoscopy)
Tumour located in a bladder diverticulum
Investigating physician concludes that en bloc resection is not technically possible
Pregnancy
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