En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

NCT05223491 | Completed

• 1 other identifier: En Bloc
• Study Type: interventional
• Target: 220
• Locations: 5 countries
• Sites: 11

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.

Conditions

Non-muscle Invasive Bladder Cancer

Keywords

en bloc; TURB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Detrusor muscle in specimen

  Within one week from surgery

• Recurrence free survival

  4 months

Study Arms (2)

En Bloc

EXPERIMENTAL

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

Procedure: En Bloc resection

Conventional TURB

ACTIVE COMPARATOR

The bladder tumour will be removed by conventional piecemeal resection.

Procedure: Conventional TURB

Interventions

En Bloc resection PROCEDURE

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

En Bloc

Conventional TURB PROCEDURE

Tumour is resected piecemeal.

Conventional TURB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jørgen Bjerggaard Jensen: lead
• University of Aarhus: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (11)

Department of Urology, Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Department of Urology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Department of Urology, Herlev Hospital

Herlev, Denmark

Location

Department of Urology, Regional Hospital Gødstrup

Holstebro, 7500, Denmark

Location

Department of Urology, Odense University Hospital

Odense, 5000, Denmark

Location

Department of Urology, Zealand University Hospital

Roskilde, 4000, Denmark

Location

Dept. of Urology, Hospital Lilelbælt, Vejle

Vejle, 7100, Denmark

Location

Dept. of Urology, North Estonia Medical Centre

Tallinn, 13419, Estonia

Location

Dept. of Urology, Turku University Hospital

Turku, 20521, Finland

Location

Urological Center, Paula Stradina Clinical University Hospital

Riga, LV-1002, Latvia

Location

Department of Urology, Vestfold Hospital

Tønsberg, 3103, Norway

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, DMSc

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 4, 2022
• Study Start: March 17, 2022
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 16, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1); NO (1); ES (1); FI (1); DK (7)