En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Not Applicable

Recruiting

• Conditions: Non-muscle Invasive Bladder Cancer
• Interventions: Procedure: En Bloc resection; Procedure: Conventional TURB

• Registration Number: NCT05223491
• Lead Sponsor: Jørgen Bjerggaard Jensen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-04
• Study Start: 2022-03-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
En Bloc	En Bloc resection	The bladder tumour will be resected en bloc and removed in total, if possible.
Conventional TURB	Conventional TURB	The bladder tumour will be removed by conventional piecemeal resection.

Primary Outcome Measures

Name	Time	Method
Unaltered pathological T-stage	4 months	Proportion of patients with unaltered pathological T-stage following central pathology revision, reTURB, or cystectomy compared to initial T-stage description from TURB.

Secondary Outcome Measures

Name	Time	Method
Recurrence free survival	4 months	Proportion of patients with recurrences at 4 months follow-up cystoscopy
Detrusor muscle in specimen	Within one week from surgery	Prevalence of detrusor muscle in specimen by pathological examination

Trial Locations

Locations (8)

Urological Center, Paula Stradina Clinical University Hospital; 🇱🇻 Riga, Latvia

Department of Urology, Vestfold Hospital; 🇳🇴 Tønsberg, Norway

Department of Urology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Urology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Urology, Herlev Hospital; 🇩🇰 Herlev, Denmark

Department of Urology, Regional Hospital Gødstrup; 🇩🇰 Holstebro, Denmark

Department of Urology, Odense University Hospital; 🇩🇰 Odense, Denmark

Department of Urology, Zealand University Hospital; 🇩🇰 Roskilde, Denmark