Status:

RECRUITING

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Lead Sponsor:

Jørgen Bjerggaard Jensen

Collaborating Sponsors:

University of Aarhus

Novo Nordisk A/S

Conditions:

Non-muscle Invasive Bladder Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 qual...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 17 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

220 Patients enrolled

Trial Details

Trial ID

NCT05223491

Start Date

March 17 2022

End Date

December 31 2026

Last Update

June 13 2023

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Department of Urology, Aalborg University Hospital

Aalborg, Denmark, 9100

2

Department of Urology, Aarhus University Hospital

Aarhus, Denmark, 8200

3

Department of Urology, Herlev Hospital

Herlev, Denmark

4

Department of Urology, Regional Hospital Gødstrup

Holstebro, Denmark, 7500