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Ongoing Projects > NBI Study

The Global Randomized NBI Bladder Cancer study

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

Primary study objective:

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)

 

Secondary study objectives:

To assess the persistence/recurrence of tumour at first follow up (3 months) after Narrow Band Imaging and TURB or White Light TURB in patients with NMIBC

To assess the peri-operative morbidity (30 days) of TURB between NBI and WL resection by using the Clavien score

To define risk factors for the development of peri-operative morbidity after instrumental treatment

To assess the recurrence rate related to the surgeon performing the procedure

To assess the recurrence rate related to additional treatment following TURB

 

  • Inclusion of data on all primary patients undergoing TURB treated.

  • There is no minimum or maximum of number of sites participating in this study, however, all sites must receive prior approval of the CROES council.

  • Subject to the approval of the CROES council, the lead investigator at study sites should preferably be a member of the Endourological Society and in good standing. Subject to the approval of the CROES council, study sites may be proposed by the members from the

  • Steering committee or on recommendation from a third party.

  • Electronic database will be maintained at the central data collection site selected by the CROES council and shall be updated on a regular basis as determined by the CROES council. A manager, selected by the CROES council, at the central data collection site will maintain and coordinate the data collection.  

  • Prior to approval of the site by the CROES council, for quality assurance, an IRB approval will be provided to the central data collection centre.

  • The members of the study group will receive feedback on the data collected on a regular basis, as determined by the CROES council. 

  • The data analysis shall be the responsibility of the Steering committee for the study group.

  • The Steering committee shall be comprised of 11 international members including a chairman. A good balance among the different treatment specialists is desirable. Representatives of the CROES council may be joining during the Steering committee meetings. 

     

    IRB Approval

    Download the NBI protocol 

    Eudractnumber: 2010-019576-68

    Download the informed consent

     

    Seiji Naito (Japan)
    Jean de la Rosette (the Netherlands)
    Ferran Algaba (Spain)
    Ying-Hao Sun
    Luc Valiquette (Canada)
    Paolo Puppo (Italy)
    Marko Babjuk (Czech Republik)
    Rik Bryan (UK)
    Harry Herr (USA)
    Mark Soloway (USA)

    Country Centre PI
    Austria Medical university of Vienna    Schmidbauer
    Canada CHUM McCormack
    Canada Montreal Hospital McGill University Kassouf
    China Beijing Tongren Hospital Qiao
    China Changhai Hospital Sun
    China The Chinese university of Hong Kong Chan
    Czech Republic Hospital Motol Brisuda
    India MPUH Desai
    Italy AOS Paolo Teaching Hospital, University of Milan Montanari
    Japan Hokkaido University Shinohara
    Japan Kumamoto University Eto
    Japan Kyoto University Matsui
    Japan Kyushu University Naito
    Japan Miyazaki University Kamoto
    Korea University College of Medicine Korea Choi
    Norway St. Olavs Arum
    Romania Saint John Emergency Clinical Hospital Gaevlete
    Russia Moscow Institute of Urology Apolikhin
    Spain Hospital Clínic de Barcelona Alcaraz
    The Netherlands AMC de Reijke
    Turkey Cerahpasa School of Medicine Obek
    Turkey Necmettin Erbakan Univ, Meram Medical School Kilinc
    UAE Dubai hospital  Farahat
    USA Duke U.S.A Inman
    USA Mayo Clinic Arizona Humphreys
    USA Tulane University Thomas
    Mr. Haruhito Morishima
    Mr. Rick Harbuck
    Mr. Luke Calcraft

    Olympus is committed to helping healthcare professionals save lives with our diagnostic and therapeutic technology. We work with physicians each day, matching our innovative capabilities in medical technology and precision manufacturing with their clinical skills to provide the best possible outcomes for patients and society.

    Our institutional knowledge, obtained from decades of experience, allows us to combine cutting-edge innovation with state-of-the-art solutions while providing strategic business counsel, training and educational opportunities for doctors and nurses.

    Aiming to set new standards, Olympus has developed advanced imaging technologies that assist in the visualization of minute lesions and offer remarkably clear views of anatomical structures and fine capillaries. 

    By spurring further advances in technology, Olympus will maintain its dedication to enhancing minimally invasive procedures with our leading medical technologies and operational support systems.
    We are convinced that these endeavors will contribute to a better quality of life for patients.

    MANUSCRIPTS PUBLISHED/IN PREPARATION

    1) The Clinical Research Office of the Endourology Society (CROES) multicentre randomised trial of narrow band imaging-assisted transurethral resection (TURBT) versus conventional white light-assisted TURBT in primary non-muscle-invasive bladder cancer patients: trial protocol and 1-year results

    Seiji Naito, Ferran Algaba, Marko Babjuk, Richard T. Bryan, Ying-Hao Sun, Luc Valiquette, Jean de la Rosette on behalf of the CROES NBI Global Study Group 

    In press European Urology

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