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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05223491
Other study ID # En Bloc
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 17, 2022
Est. completion date December 31, 2026

Study information

Verified date June 2023
Source Aarhus University Hospital
Contact Jørgen Bjerggaard J, Professor MD
Phone 0045 78452617
Email bjerggaard@skejby.rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date December 31, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
En Bloc resection
Tumour is resected and removed from the bladder in one piece, if possible.
Conventional TURB
Tumour is resected piecemeal.

Locations

Country Name City State
Denmark 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
Latvia Urological Center, Paula Stradina Clinical University Hospital Riga
Norway Department of Urology, Vestfold Hospital Tønsberg

Sponsors (3)

Lead Sponsor Collaborator
Jørgen Bjerggaard Jensen Novo Nordisk A/S, University of Aarhus

Countries where clinical trial is conducted

Denmark,  Latvia,  Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unaltered pathological T-stage Proportion of patients with unaltered pathological T-stage following central pathology revision, reTURB, or cystectomy compared to initial T-stage description from TURB. 4 months
Secondary Detrusor muscle in specimen Prevalence of detrusor muscle in specimen by pathological examination Within one week from surgery
Secondary Recurrence free survival Proportion of patients with recurrences at 4 months follow-up cystoscopy 4 months
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