The Clinical Research Office of the Endourological Society (CROES) Multicentre Randomised Trial of Narrow Band Imaging-Assisted Transurethral Resection of Bladder Tumour (TURBT) Versus Conventional White Light Imaging-Assisted TURBT in Primary Non-Muscle-invasive Bladder Cancer Patients: Trial Protocol and 1-year Results
Abstrakt
Background: White light (WL) is the established imaging modality for transurethral resection of bladder tumour (TURBT). Narrow band imaging (NBI) is a promising addition.
Objectives: To compare 12-mo recurrence rates following TURBT using NBI versus WL guidance. Design, setting, and participants: The Clinical Research Office of the Endourological Society (CROES) conducted a prospective randomised single-blind multicentre study.
Patients with primary non-muscle-invasive bladder cancer (NMIBC) were randomly assigned 1: 1 to TURBT guided by NBI or WL. Intervention: TURBT for NMIBC using NBI or WL.
Outcome measurements and statistical analysis: Twelve-month recurrence rates were compared by chi-square tests and survival analyses. Results and limitations: Of the 965 patients enrolled in the study, 481 patients underwent WL-assisted TURBT and 484 patients received NBI-assisted TURBT.
Of these, 294 and 303 patients, respectively, completed 12-mo follow-up, with recurrence rates of 27.1% and 25.4%, respectively (p = 0.585, intention-to-treat [ITT] analysis). In patients at low risk for disease recurrence, recurrence rates at 12 mo were significantly higher in the WL group compared with the NBI group (27.3% vs 5.6%; p = 0.002, ITT analysis).
Although TURBT took longer on average with NBI plus WL compared with WL alone (38.1 vs 35.0 min, p = 0.039, ITT; 39.1 vs 35.7 min, p = 0.047, per protocol [PP] analysis), lesions were significantly more often visible with NBI than with WL (p = 0.033).Possible limitations were lack of uniformity of surgical resection, data on smoking status, central pathology review, and specific data regarding adjuvant intravesical instillation therapy. Patient summary: Use of a narrow band imaging technique might provide greater detection of bladder tumours and subsequent treatment leading to reduced recurrence in low-risk patients.