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)

Paolo Puppo (Italy)

Richard Bryan (UK)

Jean de la Rosette (Netherlands)

Juan Palou-Redorta (Spain)

Mark Babjuk (Czech Republic)

Harry Herr (USA)

Mark Soloway (USA)

Rolf Muschter (Germany)

Ferran Algaba (Spain)

Ying-hao Sun (China)

 

 

Canada	CHUM	McCormack
Canada	McGill University	Kassouf
China	Beijing Tongren Hospital	Qiao
China	Changhai Hospital	Sun
China	Prince of Wales Hospital	Chan
Czech Republic	Dept. of Urology, Hospital Motol	Brisuda
India	MPUH	Desai
Italy	Università di Genova	Puppo
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
Spain	Hospital Clínic de Barcelona	Alcaraz
The Netherlands	AMC	de Reijke
USA	Duke U.S.A	Inman

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