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

• Published in: Actas urológicas españolas (English ed.) 2024-09, Vol.48 (7), p.512-520
• Main Authors: Trelles Guzmán, C.R., Linares Espinós, E., Ríos González, E., Alonso Dorrego, J.M., Aguilera Bazán, A., Jiménez Romero, M.E., Martínez-Piñeiro, L.
• Format: Article
• Language: eng ; spa
• Subjects: Bladder carcinoma; Carcinoma vesical; IMAGE1 S; IMAGE1S; Recurrencia tumoral; Resección transuretral; Transurethral resection; Tumor recurrence
• ISSN: 2173-5786; 2173-5786
• DOI: 10.1016/j.acuroe.2023.12.005

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. 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. 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. 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). 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. La mayor definición de imagen de la tecnología IMAGES1, mejorará la detección de tumores y logrará un aumento de resecciones completas y probable impacto en una reducción de recurrencias. El objetivo primario fue comparar la tasa de recurrencia tras Resección Transuretral de vejiga (RTU) asistido con IMAGE1S v/s luz blanca; el objetivo secundario fue comparar la tasa de complicaciones según Clavien-Dindo (CD) a los 12 meses de seguimiento. Ensayo clínico prospectivo, aleatorizado, cegado; secuencia 1:1. Se analizaron las tasas de recurrencia y complicaciones según CD mediante pruebas de chi cuadrado/U Mann-Whitney y la Supervivencia libre de recidiva (SLR), mediante curvas de Kaplan-Meier. Se utilizó la clasificación de riesgo de la Asociación Europea de Urología (EAU) 2021. El análisis se realizó en 103 participantes, IMAGE1S: 49 y luz blanca: 54 con una tasa de recurrencia de 12.2% y 25.9% respectivamente (P = .080). En el grup