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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
220
Tumour is resected and removed from the bladder in one piece, if possible.
Tumour is resected piecemeal.
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
...and 1 more locations
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.
Time frame: 4 months
Detrusor muscle in specimen
Prevalence of detrusor muscle in specimen by pathological examination
Time frame: Within one week from surgery
Recurrence free survival
Proportion of patients with recurrences at 4 months follow-up cystoscopy
Time frame: 4 months
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