An interventional study of En Bloc resection and Conventional TURB in Non-muscle Invasive Bladder Cancer, sponsored by Jørgen Bjerggaard Jensen. Completed at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Jørgen Bjerggaard Jensen · Not applicable, Interventional, and Diagnostic
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.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's enrollment of 220 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Jørgen Bjerggaard Jensen is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The bladder tumour will be resected en bloc and removed in total, if possible.
Procedure: En Bloc resection
The bladder tumour will be removed by conventional piecemeal resection.
Procedure: Conventional TURB
Tumour is resected and removed from the bladder in one piece, if possible.
Tumour is resected piecemeal.
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.
Time frame: 4 months
Detrusor muscle in specimen
Prevalence of detrusor muscle in specimen by pathological examination
Time frame: Within one week from surgery
Recurrence free survival
Proportion of patients with recurrences at 4 months follow-up cystoscopy
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Dec 2025, 45 months.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Non-Muscle Invasive Bladder Neoplasms →
Jørgen Bjerggaard Jensen