En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Non-muscle Invasive Bladder Cancer Clinical Trial

Official title:

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05223491
• Other study ID #: En Bloc
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Aarhus University Hospital
• Contact: Jørgen Bjerggaard J, Professor MD
• Phone: 0045 78452617
• Email: bjerggaard[@]skejby.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• En Bloc resection
Tumour is resected and removed from the bladder in one piece, if possible.
• Conventional TURB
Tumour is resected piecemeal.

Locations

Country	Name	City	State
Denmark	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
Latvia	Urological Center, Paula Stradina Clinical University Hospital	Riga
Norway	Department of Urology, Vestfold Hospital	Tønsberg

Sponsors (3)

Lead Sponsor	Collaborator
Jørgen Bjerggaard Jensen	Novo Nordisk A/S, University of Aarhus

Countries where clinical trial is conducted

Denmark,  Latvia,  Norway, 

Outcome

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