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NCT Number: NCT05223491

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

En Bloc resection

Procedure

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

Conventional TURB

Procedure

Tumour is resected piecemeal.

Primary outcomes

  1. Unaltered pathological T-stage

    Time frame: 4 months

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

Secondary outcomes

  1. Detrusor muscle in specimen

    Time frame: Within one week from surgery

    Prevalence of detrusor muscle in specimen by pathological examination

  2. Recurrence free survival

    Time frame: 4 months

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

Sponsors and collaborators

Lead sponsor

Jørgen Bjerggaard Jensen

Other

Collaborators

  • Novo Nordisk A/S
  • University of Aarhus

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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