THE GLOBAL RANDOMIZED NBI BLADDER CANCER STUDY -A Multi- Centre, International study to compare use of Narrow Band Imaging (NBI) versus White light (WL) during TURB to assess recurrence of bladder cancer in terms of safety and efficacy.

Completed

Conditions: Bladder cancer

Registration Number: NL-OMON20575

Lead Sponsor: Clinical Research Office of the Endourological Society (CROES)

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

1. Signed informed consent;

2. Patients scheduled for treatment of a primary NMIBC;

Exclusion Criteria

1. Gross hematuria at the time of TURB. (Note: Gross hematuria is defined as a heavy bladder bleeding resulting in marked amounts of blood in the urine, which may interfere with cystoscopy);

2. Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the recurrence rate at 1 year following Narrow Band Imaging and TURB (Arm A) with White Light Trans Urethral Resection of Bladder cancer (TURB) (Arm B) in patients with non muscle invasive (NMIBC Ta/T1) bladder cancer.

Secondary Outcome Measures

Name	Time	Method
1. To assess the recurrence of tumour at first follow up (3 months) after Narrow Band Imaging and TURB or White Light TURB in patients with NMIBC;<br /><br>2. To assess the peri-operative morbidity (30 days) of TURB between NBI and WL resection by using the Clavien score;<br /><br>3. To define risk factors for the development of peri-operative morbidity after instrumental treatment;<br /><br>4. To assess the recurrence rate related to the surgeon performing the procedure;<br /><br>5. To assess the recurrence rate related to additional treatment following TURB.