En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

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 Overview

• Status: Recruiting
• Conditions: Non-muscle Invasive Bladder Cancer
• Intervention / Treatment: Procedure: En Bloc resection; Procedure: Conventional TURB

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jørgen Bjerggaard J, Professor MD; Phone Number: 0045 78452617; Email: bjerggaard@skejby.rm.dk
• Study Contact Backup: Name: Ninna Kjær Nielsen, MD; Phone Number: 0045 30915431; Email: ninna.nielsen@rm.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9100
    • Recruiting
    • Department of Urology, Aalborg University Hospital
    • Contact: Knud Fabrin, MD
  • Aarhus, Denmark, 8200
    • Recruiting
    • Department of Urology, Aarhus University Hospital
    • Contact: Ninna Kjær Nielsen, MD
  • Herlev, Denmark
    • Recruiting
    • Department of Urology, Herlev Hospital
    • Contact: Gitte W Lam, MD
  • Holstebro, Denmark, 7500
    • Recruiting
    • Department of Urology, Regional Hospital Gødstrup
    • Contact: Kasper Olsen, MD
  • Odense, Denmark, 5000
    • Recruiting
    • Department of Urology, Odense University Hospital
    • Contact: Per Holt, MD
  • Roskilde, Denmark, 4000
    • Recruiting
    • Department of Urology, Zealand University Hospital
    • Contact: Juan Luis Vásquez, MD
• Latvia
  • Riga, Latvia, LV-1002
    • Recruiting
    • Urological Center, Paula Stradina Clinical University Hospital
    • Contact: Egils Vjaters
    • Contact: Karlis Kaufmanis
• Norway
  • Tønsberg, Norway, 3103
    • Recruiting
    • Department of Urology, Vestfold Hospital
    • Contact: Erik Haug, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: En Bloc; The bladder tumour will be resected en bloc and removed in total, if possible.	Procedure: En Bloc resection; Tumour is resected and removed from the bladder in one piece, if possible.
Active Comparator: Conventional TURB; The bladder tumour will be removed by conventional piecemeal resection.	Procedure: Conventional TURB; Tumour is resected piecemeal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detrusor muscle in specimen	Prevalence of detrusor muscle in specimen by pathological examination	Within one week from surgery
Recurrence free survival	Proportion of patients with recurrences at 4 months follow-up cystoscopy	4 months

Collaborators and Investigators

• Sponsor: Jørgen Bjerggaard Jensen
• Collaborators: Novo Nordisk A/S; University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: en bloc; TURB
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: En Bloc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No