En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT05223491|
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : June 15, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-muscle Invasive Bladder Cancer||Procedure: En Bloc resection Procedure: Conventional TURB||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer|
|Actual Study Start Date :||March 17, 2022|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2026|
Experimental: En Bloc
The bladder tumour will be resected en bloc and removed in total, if possible.
Procedure: En Bloc resection
Tumour is resected and removed from the bladder in one piece, if possible.
Active Comparator: Conventional TURB
The bladder tumour will be removed by conventional piecemeal resection.
Procedure: Conventional TURB
Tumour is resected piecemeal.
- Unaltered pathological T-stage [ Time Frame: 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.
- Detrusor muscle in specimen [ Time Frame: Within one week from surgery ]Prevalence of detrusor muscle in specimen by pathological examination
- Recurrence free survival [ Time Frame: 4 months ]Proportion of patients with recurrences at 4 months follow-up cystoscopy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05223491
|Contact: Jørgen Bjerggaard J, Professor MD||0045 firstname.lastname@example.org|
|Contact: Ninna Kjær Nielsen, MD||0045 email@example.com|
|Department of Urology, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9100|
|Contact: Knud Fabrin, MD|
|Department of Urology, Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Ninna Kjær Nielsen, MD|
|Department of Urology, Herlev Hospital||Not yet recruiting|
|Contact: Gitte W Lam, MD|
|Department of Urology, Regional Hospital West Jutland||Not yet recruiting|
|Holstebro, Denmark, 7500|
|Contact: Erik Hansen, MD|
|Department of Urology, Odense University Hospital||Not yet recruiting|
|Odense, Denmark, 5000|
|Contact: Thor Knak Jensen, MD|
|Department of Urology, Zealand University Hospital||Not yet recruiting|
|Roskilde, Denmark, 4000|
|Contact: Juan Luis Vásquez, MD|