Randomized clinical trial on the use of IMAGE1 S LIGHT (SPIES) vs. white light in the prevention of recurrence during transurethral resection of bladder tumors: Analysis after 12-month follow-up

C R Trelles Guzmán; E Linares Espinós; E Ríos González; J M Alonso Dorrego; A Aguilera Bazán; M E Jiménez Romero; L Martínez-Piñeiro

doi:10.1016/j.acuroe.2023.12.005

Randomized clinical trial on the use of IMAGE1 S LIGHT (SPIES) vs. white light in the prevention of recurrence during transurethral resection of bladder tumors: Analysis after 12-month follow-up

Actas Urol Esp (Engl Ed). 2023 Dec 28:S2173-5786(23)00141-5. doi: 10.1016/j.acuroe.2023.12.005. Online ahead of print.

[Article in English, Spanish]

Authors

C R Trelles Guzmán¹, E Linares Espinós², E Ríos González³, J M Alonso Dorrego³, A Aguilera Bazán³, M E Jiménez Romero⁴, L Martínez-Piñeiro³

Affiliations

¹ Servicio de Urología, Área de Gestión Sanitaria Campo de Gibraltar Este, Spain; Universidad Autónoma de Madrid, Madrid, Spain.
² Servicio de Urología, Hospital Universitario La Paz, Madrid, Spain. Electronic address: estefania.linares@salud.madrid.org.
³ Servicio de Urología, Hospital Universitario La Paz, Madrid, Spain.
⁴ Servicio de Urología, Área de Gestión Sanitaria Campo de Gibraltar Este, Spain; Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain.

PMID: 38159804
DOI: 10.1016/j.acuroe.2023.12.005

Abstract

Introduction: The improved image resolution of IMAGE1 S technology will increase tumor detection, achieve a greater number of complete resections, and would probably have an impact on the reduction of recurrences.

Aim: The primary objective was to compare the recurrence rates of IMAGE1 S vs. white light during transurethral resection of the bladder (TUR); the secondary objective was to compare the complication rates according to Clavien-Dindo (CD) at 12 months of follow-up.

Methods: Prospective, randomized 1:1, blinded clinical trial. Recurrence and complication rates according to CD were analyzed using chi-square/U Mann-Whitney tests and recurrence-free survival (RFS) using Kaplan-Meier curves. The European Association of Urology (EAU) 2021 scoring model was used.

Results: The analysis included 103 participants; 49 were assigned to the IMAGE1 S group and 54 to the white light group. Recurrence rates were 12.2% and 25.9%, respectively (P = .080). The low and intermediate risk group had a lower recurrence rate with IMAGE1 S (7.7% vs. 30.8%, P = .003) and a higher RFS with IMAGE1 S (85.2% vs. 62.8% Log Rank: 0.021), with a Hazard Ratio of 0.215 (95% CI: 0.046-0.925). No differences were observed in the high and very high-risk groups. Complications were mostly grade I and rates were similar between both groups (IMAGE1 S 20.4% vs. white light 7.4% P = .083).

Conclusions: There were no differences in the recurrence rates between groups. However, the low and intermediate risk group had a lower recurrence rate with IMAGE1 S. In addition, perioperative complication rates were not higher.

Keywords: Bladder carcinoma; Carcinoma vesical; IMAGE1 S; IMAGE1S; Recurrencia tumoral; Resección transuretral; Transurethral resection; Tumor recurrence.