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.

A 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.

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.

The 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.

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 resolution of the mucosa and small vascular structures increases.