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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20575
Enrollment
1000
Registered
2012-10-02
Start date
2010-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

White light cystoscopy is currently a standard procedure for removing bladder cancers. Narrow Band Imaging (NBI) is a new endoscopic technique using a special light filter resulting in a high contrast

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Signed informed consent; 2. Patients scheduled for treatment of a primary NMIBC; 3. Patients should be aged 18 years or older; 4. No tumours in the upper urinary tract; 5. No previous irradiation of the pelvis.

Exclusion criteria

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; 3. Pregnant (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter); 4. Conditions associated with a risk of poor protocol compliance.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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; 2. To assess the peri-operative morbidity (30 days) of TURB between NBI and WL resection by using the Clavien score; 3. To define risk factors for the development of peri-operative morbidity after instrumental treatment; 4. To assess the recurrence rate related to the surgeon performing the procedure; 5. To assess the recurrence rate related to additional treatment following TURB.—

Contacts

Public ContactSonja Rees Vellinga, van
info@croesoffice.org+31 (0)20 56 66377

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)