A Multi-Centre, international study to compare use of Narrow Band Imaging (NBI) versus White light Imaging (WLI) during TURBT to assess recurrence of bladder cancer in terms of safety and efficacy.

A Multi-Centre, international study to compare use of Narrow Band Imaging (NBI) versus White light Imaging (WLI) during TURBT to assess recurrence of bladder cancer in terms of safety and efficacy. - THE GROBAL RANDOMIZED NBI BLADDER CANCER STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004545

Enrollment

980

Registered

2010-11-15

Start date

2010-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non muscle-invasive bladder cancer (NMIBC)

Interventions

All patients in Group A will be treated with WL and NBI. The surgeon performing the follow up must preferably be different from the one performing the TURB. Patients will be followed during hospital s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled for treatment of a primary NMIBC Patients should be aged 18 years or older No tumours in the upper urinary tract No previous irradiation of the pelvis

Exclusion criteria

Exclusion criteria: 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). Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. Pregnant or breast-feeding (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). Why, we do not inject anything

Design outcomes

Primary

Measure	Time frame
All lesions must be histological confirmed. The proportion of subjects with histology-confirmed tumours (Ta or T1) who have at least one such tumor found by NBI but not by white light cystoscopy. Comparison of the proportions of Group A and Group B subjects who undergo TURB for a histology-confirmed Ta or T1 tumour who have a recurrence (histology confirmed Ta or T1) found at either three or twelve months.	—

Measure

Time frame

All lesions must be histological confirmed. The proportion of subjects with histology-confirmed tumours (Ta or T1) who have at least one such tumor found by NBI but not by white light cystoscopy. Comparison of the proportions of Group A and Group B subjects who undergo TURB for a histology-confirmed Ta or T1 tumour who have a recurrence (histology confirmed Ta or T1) found at either three or twelve months.

—

Countries

Japan,North America,Europe

Contacts

Public ContactYoshiyuki Matsui

Kyoto University Faculty of Medicine, the Department of Urology

ym1108@kuhp.kyoto-u.ac.jp075-751-3337

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026