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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.


- candidate number13398
- NTR NumberNTR3645
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-okt-2012
- Secondary IDs072010 CROES
- Public TitleTHE 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.
- Scientific TitleTHE 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.
- ACRONYMCROES NBI STUDY
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedBladder carinoma
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2010
- planned closingdate31-dec-2013
- Target number of participants1000
- InterventionsWhite 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 resolution of the mucosa and small vascular structures increases.
- Primary outcomeTo 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 outcome1. 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.
- TimepointsThe study consists of a screening evaluation followed by cystoscopy/TURB/biopsies and two follow up cystoscopic examinations at three and twelve months after the initial cystoscopy/TURB/biopsy at least depending on stage and grade of the tumour(s). Since it is not always possible to schedule the follow up visits at exactly three and twelve months, a window of plus/minus two weeks will be accepted. However, the Steering Committee recommends a follow up period of 24 months.
- Trial web sitewww.croesoffice.org
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Sonja Rees Vellinga, van
- CONTACT for SCIENTIFIC QUERIES Sonja Rees Vellinga, van
- Sponsor/Initiator Clinical Research Office of the Endourological Society (CROES)
- Funding
(Source(s) of Monetary or Material Support)
Olympus
- PublicationsN/A
- Brief summaryA new development in imaging is the narrow band cystoscopy. This technique has been developed by Olympus and is now ready for clinical evaluation in Urology. Narrow Band Imaging (NBI) is a high-resolution endoscopic technique that enhances the fine structure of the mucosal surface without the use of dyes. NBI is based upon the phenomenon that the depth of light penetration depends on its wavelength; the longer the wavelength, the deeper the penetration. Blue light penetrates only superficially, whereas red light penetrates into the deeper layers. The first prototype NBI system (Olympus Corp, Tokyo, Japan) is based upon a light source with sequential red, green, and blue (RGB) illumination. NBI has been investigated in several gastro- intestinal diseases and this technique has shown to be beneficial. In Urology there is limited experience for the role of NBI in detecting bladder cancer but early results are promising. However, NBI may have most utility in the operating theatre where a more thorough primary tumour resection may be achievable, as well as reducing the number of tumours that are missed. This could impact the subsequent recurrence rate, resulting in patients experiencing fewer cystoscopic/biopsies/TUR procedures during their disease course, and ultimately leading to a better quality of life and a reduction in the cost of their care.
- Main changes (audit trail)
- RECORD2-okt-2012 - 18-dec-2013


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