Non-muscle Invasive Bladder Cancer
Conditions
Keywords
en bloc, TURB
Brief 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.
Interventions
PROCEDUREEn Bloc resection
Tumour is resected and removed from the bladder in one piece, if possible.
PROCEDUREConventional TURB
Tumour is resected piecemeal.
Sponsors
Jørgen Bjerggaard Jensen
University of Aarhus
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unaltered pathological T-stage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detrusor muscle in specimen | Within one week from surgery | Prevalence of detrusor muscle in specimen by pathological examination |
| Recurrence free survival | 4 months | Proportion of patients with recurrences at 4 months follow-up cystoscopy |
Countries
Denmark, Estonia, Finland, Latvia, Norway
Outcome results
None listed