The Global randomized NBi bladder cancer study
A Multi-Centre, International study to compare the use of Narrow Band Imaging (NBI) versus White light (WL) to assess recurrence of bladder cancer in terms of safety and efficacy.

The standard in diagnostics of UC of the bladder is the visual approach
including the need for biopsies or transurethral resection. These invasive
procedures provide good results for bladder tumours (cystoscopy and
transurethral biopsies/resection). Although most of the bladder tumours can be
identified with white light cystoscopy, it has been shown that especially in
high-grade tumours areas of carcinoma in situ are missed . And in case of a
positive urinary cytology without visual abnormalities, so-called random
biopsies have to be taken to demonstrate the presence of carcinoma in situ.
Undetected tumours can later appear as a recurrence, and some might become
invasive, highlighting the need to develop alternative endoscopic methods to
detect bladder lesions more accurately. A more complete identification may at
the very least render the bladder more receptive to successful intravesical
therapy , and more importantly, may allow for greater detection of high
grade/stage tumours, which may alter treatment decisions
The use of photodynamic agents e.g. HEXVIX has been shown to be helpful in
these cases in order to accomplish a better resection, identify *overlooked*
tumours, and to target biopsies in case of a positive cytology only. This
translates in more complete resection, reducing the recurrence rate of
non-invasive tumours and in more appropriate treatments .
Another 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-enterological 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 bladder cancer (NMIBC).

The purpose of this study is to investigate further the value of Narrow Band
Imaging (NBI) cystoscopy during surgery compared with white light cystoscopy
(WL).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. For this technique, special
instruments were developed, with the push on a button during the operation the
surgeon can change from WL to NBI. This could provide better sight of the
bladder cancer during the surgery. If you see the cancer better, the surgery
can be performed better

This study is a randomized multi-center study to compare the safety (morbidity)
and efficacy between NBI assisted TURB and WL assisted TURB. Each participating
center must submit the protocol to their local MEC and each participating
centre is responsible for the insurance of their patients. The Academical
Medical Center in Netherlands is only responsible for the patients that are
treated in their hospital.

NBI vs white light

-