En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Last updated: June 12, 2023
Sponsor: Jørgen Bjerggaard Jensen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Cancer

Treatment

Conventional TURB

En Bloc resection

Clinical Study ID

NCT05223491
En Bloc
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inone procedure

Exclusion

Exclusion Criteria:

  • Clinically suspected muscle invasive bladder cancer (invasion in to bladder muscle orextravesical extension visible on CT or solid tumour without papillary elements seenat cystoscopy)
  • Tumour located in a bladder diverticulum
  • Investigating physician concludes that en bloc resection is not technically possible
  • Pregnancy

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Conventional TURB
Phase:
Study Start date:
March 17, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Department of Urology, Aalborg University Hospital

    Aalborg, 9100
    Denmark

    Active - Recruiting

  • Department of Urology, Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Department of Urology, Herlev Hospital

    Herlev,
    Denmark

    Active - Recruiting

  • Department of Urology, Regional Hospital Gødstrup

    Holstebro, 7500
    Denmark

    Active - Recruiting

  • Department of Urology, Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

  • Department of Urology, Zealand University Hospital

    Roskilde, 4000
    Denmark

    Active - Recruiting

  • Urological Center, Paula Stradina Clinical University Hospital

    Riga, LV-1002
    Latvia

    Active - Recruiting

  • Department of Urology, Vestfold Hospital

    Tønsberg, 3103
    Norway

    Active - Recruiting

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