Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The bladder tumour will be resected en bloc and removed in total, if possible.

The bladder tumour will be removed by conventional piecemeal resection.

Tumour is resected and removed from the bladder in one piece, if possible.

En Bloc resection

Conventional TURB

Jørgen Bjerggaard J, Professor MD

Ninna Kjær Nielsen, MD

Knud Fabrin, MD

Gitte W Lam, MD

Kasper Olsen, MD

Per Holt, MD

Juan Luis Vásquez, MD

Egils Vjaters

Karlis Kaufmanis

Erik Haug, MD

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.

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Proportion of patients with unaltered pathological T-stage following central pathology revision, reTURB, or cystectomy compared to initial T-stage description from TURB.

Prevalence of detrusor muscle in specimen by pathological examination

Proportion of patients with recurrences at 4 months follow-up cystoscopy

University of Aarhus

Novo Nordisk A/S

Jørgen Bjerggaard Jensen

Professor, DMSc

Antineoplastic Agents

All Drugs and Chemicals

Mitomycins

Mitomycin

En-bloc resection will be performed at each center based on local clinical practice and available instruments. Laser resection, hydrodissection with HybridKnife® or electric resection are allowed. All procedures, including cTURB, must be performed with an imaging enhancing technique (PDD / NBI at surgeon's discretion). After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.

En-Bloc TURB

En-bloc resection will be performed at each center based on local clinical practice and available instruments. After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.

Shahrokh Shariat, M.D.

Based on current evidence, we hypothesize that eTURB represents an improvement in the surgical management of NMIBC. The resection is more precise and complete compared to cTURB. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy.

To answer these questions, we designed a RCT comparing eTURB with cTURB. Primary outcome of our study will be the accuracy of pathological staging assessment measured by the presence of detrusor muscle in the specimen as a surrogate parameter for quality of resection.

En-bloc vs Conventional Resection of Primary Bladder Tumor

En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial

The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB

David D'Andrea

M.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer	NCT05223491	Non-muscle Inva...	En Bloc resecti... Conventional TU...	18 Years -	Aarhus University Hospital
En-bloc vs Conventional Resection of Primary Bladder Tumor	NCT03718754	Bladder Cancer	En-Bloc TURB Conventional TU...	-	Medical University of Vienna
En-bloc vs Conventional Resection of Primary Bladder Tumor	NCT03718754	Bladder Cancer	En-Bloc TURB Conventional TU...	-	Medical University of Vienna

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