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.
Article
em En, Es
| MEDLINE
| ID: mdl-38159804
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 11, 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 (Pâ¯=â¯.080). The low and intermediate risk group had a lower recurrence rate with IMAGE1 S (7.7% vs. 30.8%, Pâ¯=â¯.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% Pâ¯=â¯.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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
/
Es
Ano de publicação:
2023
Tipo de documento:
Article