Comparing two surgical methods for bladder cancer treatment
En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer
NA · Aarhus University Hospital · NCT05223491
This study is testing whether a new surgical method called En Bloc resection is better than the standard procedure for treating non-muscle invasive bladder cancer to see if it helps remove tumors more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital (other) |
| Locations | 8 sites (Aalborg and 7 other locations) |
| Trial ID | NCT05223491 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of En Bloc resection versus conventional transurethral resection (TURB) for treating non-muscle invasive bladder cancer (NMIBC). The study will assess the complete removal of tumors, specimen quality, and pathological certainty between the two surgical approaches. NMIBC has a high recurrence rate, and the trial seeks to determine if En Bloc resection can improve outcomes by addressing the limitations of TURB. It will be conducted as a multicenter randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates include individuals with primary, papillary, non-solid bladder tumors measuring between 2cm and 6cm.
Not a fit: Patients with clinically suspected muscle invasive bladder cancer or those for whom En Bloc resection is deemed technically unfeasible will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with non-muscle invasive bladder cancer.
How similar studies have performed: While the concept of En Bloc resection is promising, large randomized trials comparing it to conventional methods are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aalborg and 7 other locations
- Department of Urology, Aalborg University Hospital — Aalborg, Denmark (RECRUITING)
- Department of Urology, Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
- Department of Urology, Herlev Hospital — Herlev, Denmark (RECRUITING)
- Department of Urology, Regional Hospital Gødstrup — Holstebro, Denmark (RECRUITING)
- Department of Urology, Odense University Hospital — Odense, Denmark (RECRUITING)
- Department of Urology, Zealand University Hospital — Roskilde, Denmark (RECRUITING)
- Urological Center, Paula Stradina Clinical University Hospital — Riga, Latvia (RECRUITING)
- Department of Urology, Vestfold Hospital — Tønsberg, Norway (RECRUITING)
Study contacts
- Study coordinator: Jørgen Bjerggaard J, Professor MD
- Email: bjerggaard@skejby.rm.dk
- Phone: 0045 78452617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-muscle Invasive Bladder Cancer, en bloc, TURB