En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer
NCT ID: NCT05223491
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2022-03-17
2025-12-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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En Bloc
The bladder tumour will be resected en bloc and removed in total, if possible.
En Bloc resection
Tumour is resected and removed from the bladder in one piece, if possible.
Conventional TURB
The bladder tumour will be removed by conventional piecemeal resection.
Conventional TURB
Tumour is resected piecemeal.
Interventions
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En Bloc resection
Tumour is resected and removed from the bladder in one piece, if possible.
Conventional TURB
Tumour is resected piecemeal.
Eligibility Criteria
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Inclusion Criteria
* 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
* Tumour located in a bladder diverticulum
* Investigating physician concludes that en bloc resection is not technically possible
* Pregnancy
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Novo Nordisk A/S
INDUSTRY
Jørgen Bjerggaard Jensen
OTHER
Responsible Party
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Jørgen Bjerggaard Jensen
Professor, DMSc
Locations
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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
Dept. of Urology, Hospital Lilelbælt, Vejle
Vejle, , Denmark
Dept. of Urology, North Estonia Medical Centre
Tallinn, , Estonia
Dept. of Urology, Turku University Hospital
Turku, , Finland
Urological Center, Paula Stradina Clinical University Hospital
Riga, , Latvia
Department of Urology, Vestfold Hospital
Tønsberg, , Norway
Countries
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Other Identifiers
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En Bloc
Identifier Type: -
Identifier Source: org_study_id
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