En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Urology, Aalborg University Hospital
RECRUITING
Aalborg
Department of Urology, Aarhus University Hospital
RECRUITING
Aarhus
Department of Urology, Herlev Hospital
RECRUITING
Herlev
Department of Urology, Regional Hospital Gødstrup
RECRUITING
Holstebro
Department of Urology, Odense University Hospital
RECRUITING
Odense
Department of Urology, Zealand University Hospital
RECRUITING
Roskilde
Latvia
Urological Center, Paula Stradina Clinical University Hospital
RECRUITING
Riga
Norway
Department of Urology, Vestfold Hospital
RECRUITING
Tønsberg
Contact Information
Primary
Jørgen Bjerggaard J, Professor MD
bjerggaard@skejby.rm.dk
0045 78452617
Backup
Ninna Kjær Nielsen, MD
ninna.nielsen@rm.dk
0045 30915431
Time Frame
Start Date: 2022-03-17
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 220
Treatments
Experimental: En Bloc
The bladder tumour will be resected en bloc and removed in total, if possible.
Active_comparator: Conventional TURB
The bladder tumour will be removed by conventional piecemeal resection.
Related Therapeutic Areas
Sponsors
Leads: Jørgen Bjerggaard Jensen
Collaborators: University of Aarhus, Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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