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Inicio Actas Urológicas Españolas (English Edition) Randomized clinical trial on the use of IMAGE1 S LIGHT (SPIES) vs. white light i...
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Vol. 48. Issue 7.
Pages 512-520 (September 2024)
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Vol. 48. Issue 7.
Pages 512-520 (September 2024)
Original article
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
Ensayo clínico aleatorizado: utilización de la luz IMAGE1S (SPIES) vs. luz blanca durante la resección transuretral de tumores vesicales para la prevención de recurrencias, análisis a los 12 meses de seguimiento
C.R. Trelles Guzmána,b, E. Linares Espinósc,
Corresponding author
, E. Ríos Gonzálezc, J.M. Alonso Dorregoc, A. Aguilera Bazánc, M.E. Jiménez Romeroa,d, L. Martínez-Piñeiroc
a Servicio de Urología, Área de Gestión Sanitaria Campo de Gibraltar Este, Spain
b Universidad Autónoma de Madrid, Madrid, Spain
c Servicio de Urología, Hospital Universitario La Paz, Madrid, Spain
d Instituto de Investigación e Innovación Biomédica de Cádiz (INiBICA), Spain
Article information
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Tables (4)
Table 1. Classification of surgical complications according to the modified Clavien-Dindo system.
Table 2. Demographic characteristics, diagnosis, and recurrent tumors according to study groups.
Table 3. Intraoperative and postoperative characteristics according to study groups.
Table 4. Pathological characteristics of the postoperative findings according to study groups.
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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
IMAGE1 S
Tumor recurrence
Transurethral resection
Resumen
Introducción

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.

Objetivo

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.

Metodología

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.

Resultados

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 grupo de Riesgo bajo e intermedio la recurrencia fue menor en IMAGE1S (7.7% vs 30.8%, P = .003) y la SLR fue mayor en IMAGE1S (85.2% vs 62.8% Long Rank: 0.021) con una Hazard Ratio del 0.215 (IC 95%: 0.046–0.925). No se observó diferencias en el grupo Riesgo alto y muy alto. Las complicaciones fueron en su mayoría grado I y similares en ambos grupos (IMAGE1S 20.4% vs Luz blanca 7.4% P = .083).

Conclusiones

No hubo diferencias en la tasa de recurrencia entre grupos. Sin embargo, fue menor la recurrencia en el grupo riesgo bajo e intermedio con IMAGE1S. Además, no presentó aumento de complicaciones perioperatorias.

Palabras clave:
Carcinoma vesical
IMAGE1S
Recurrencia tumoral
Resección transuretral

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