Conventional white light imaging-assisted transurethral resection of bladder tumour (TURBT) versus IMAGE1S-assisted TURBT in non-muscle-invasive bladder cancer patients: trial protocol and 18 months results.

White light (WL) is the traditional imaging modality for transurethral resection of bladder tumour (TURBT). IMAGE1S is a likely addition. We compare 18-mo recurrence rates following TURBT using IMAGE1S versus WL guidance.

Twelve international centers conducted a single-blinded randomized controlled trial. Patients with primary and recurrent non-muscle-invasive bladder cancer (NMIBC) were randomly assigned 1:1 to TURBT guided by IMAGE1S or WL. Eighteen-month recurrence rates and subanalysis for primary/recurrent and risk groups were planned and compared by chi-square tests and survival analyses.

689 patients were randomized for WL-assisted (n = 354) or IMAGE1S-assisted (n = 335) TURBT. Of these, 64.7% had a primary tumor, 35.3% a recurrent tumor, and 4.8%, 69.2% and 26.0% a low-, intermediate-, and high-risk tumor, respectively. Overall, 60 and 65 patients, respectively, completed 18-mo follow-up, with recurrence rates of 31.0% and 25.4%, respectively (p = 0.199). In patients with primary, low-/intermediate-risk tumors, recurrence rates at 18-mo were significantly higher in the WL group compared with the IMAGE1S group (31.9% and 22.3%, respectively: p 0.035). Frequency and severity of adverse events were comparable in both treatment groups. Immediate and adjuvant intravesical instillation therapy did not differ between the groups. Potential limitations included lack of uniformity of surgical resection, central pathology review, and missing data.

There was not difference in the overall recurrence rates between IMAGE1S and WL assistance 18-mo after TURBT in patients with NMIBC. However, IMAGE1S-assisted TURBT considerably reduced the likelihood of disease recurrence in primary, low/intermediate risk patients. Identifier NCT02252549 (30-09-2014).

World journal of urology. 2021 Nov 06 [Epub ahead of print]

Jean de la Rosette, Alexey Martov, Rodolfo Hurle, Gabriel Favre, Charalampos Mamoulakis, Manuel Castanheira de Oliveira, Arnulf Stenzl, Estefania Linares-Espinós, Carlos R Trelles Guzmán, Stavros Gravas, Thomas Knoll, Mustafa Yucel Boz, Thomas Herrmann, Pilar Laguna

Department of Urology, Istanbul Medipol Mega University Hospital, Istanbul, Turkey. ., Department of Urology, Pletnew Moscow City Hospital, Moscow, Russia., Department of Urology, IRCCS Humanitas Research Hospital, Milan, Italy., Department of Urology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina., Department of Urology, University General Hospital of Heraklion, University of Crete, Medical School, Heraklion, Crete, Greece., Department of Urology, Centro Hospitalar Universitário Do Porto, Hospital de Santo António, Porto, Portugal., Department of Urology, University of Tuebingen Medical Center, Tuebingen, Germany., Department of Urology, La Paz University Hospital, Madrid, Spain., Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece., Department of Urology, Klinikum Sindelfingen-Boblingen, Germany., Department of Urology, Istanbul Medipol Mega University Hospital, Istanbul, Turkey., Department of Urology, Spital Thurgau, AG, Switzerland.

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