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

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; the secondary objective was to compare the complication rates according to Clavien-Dindo at 12 months of follow-up.

Methodolgy

Prospective, randomized 1:1, blinded clinical trial. Recurrence and complication rates according to Clavien-Dindo were analyzed using chi-square/U Mann-Whitney tests, and recurrence-free survival using Kaplan-Meier curves. The European Association of Urology 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 recurrence-free survival 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.