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En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05223491
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : June 15, 2022
Sponsor:
Collaborators:
University of Aarhus
Novo Nordisk A/S
Information provided by (Responsible Party):
Jørgen Bjerggaard Jensen, Aarhus University Hospital

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 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, is supposed to 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 ≥2cm 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.


Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer Procedure: En Bloc resection Procedure: Conventional TURB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer
Actual Study Start Date : March 17, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: En Bloc
The bladder tumour will be resected en bloc and removed in total, if possible.
Procedure: En Bloc resection
Tumour is resected and removed from the bladder in one piece, if possible.

Active Comparator: Conventional TURB
The bladder tumour will be removed by conventional piecemeal resection.
Procedure: Conventional TURB
Tumour is resected piecemeal.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05223491


Contacts
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Contact: Jørgen Bjerggaard J, Professor MD 0045 78452617 bjerggaard@skejby.rm.dk
Contact: Ninna Kjær Nielsen, MD 0045 30915431 ninna.nielsen@rm.dk

Locations
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Denmark
Department of Urology, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9100
Contact: Knud Fabrin, MD         
Department of Urology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Ninna Kjær Nielsen, MD         
Department of Urology, Herlev Hospital Not yet recruiting
Herlev, Denmark
Contact: Gitte W Lam, MD         
Department of Urology, Regional Hospital West Jutland Not yet recruiting
Holstebro, Denmark, 7500
Contact: Erik Hansen, MD         
Department of Urology, Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Thor Knak Jensen, MD         
Department of Urology, Zealand University Hospital Not yet recruiting
Roskilde, Denmark, 4000
Contact: Juan Luis Vásquez, MD         
Sponsors and Collaborators
Jørgen Bjerggaard Jensen
University of Aarhus
Novo Nordisk A/S
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Responsible Party: Jørgen Bjerggaard Jensen, Professor, DMSc, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT05223491    
Other Study ID Numbers: En Bloc
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jørgen Bjerggaard Jensen, Aarhus University Hospital:
en bloc
TURB
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases