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

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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.

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在经尿道膀胱肿瘤切除术中使用 IMAGE1 S 光(SPIES)与白光预防复发的随机临床试验:12 个月随访后的分析。
简介:IMAGE1 S 技术图像分辨率的提高将增加肿瘤检测率,实现更多的完整切除,并可能对减少复发产生影响:目的:主要目的是比较 IMAGE1 S 与白光在经尿道膀胱切除术(TUR)中的复发率;次要目的是比较随访 12 个月后根据克拉维恩-丁多(CD)标准得出的并发症发生率:方法:前瞻性、1:1 随机、盲法临床试验。方法:前瞻性、随机、1:1、盲法临床试验,根据 CD 的复发率和并发症发生率,采用卡普兰-梅耶曲线(Kaplan-Meier curves)进行卡普兰-梅耶曲线(chi-square/U Mann-Whitney tests)分析。采用了欧洲泌尿外科协会(EAU)2021评分模型:分析包括 103 名参与者;49 人被分配到 IMAGE1 S 组,54 人被分配到白光组。复发率分别为 12.2% 和 25.9%(P = 0.080)。低危和中危组使用 IMAGE1 S 的复发率较低(7.7% 对 30.8%,p = 0.003),使用 IMAGE1 S 的 RFS 较高(85.2% 对 62.8% Log Rank:0.021),危险比为 0.215(95% CI:0.046-0.925)。在高风险组和极高风险组中未观察到差异。并发症大多为 I 级,两组的发生率相似(IMAGE1 S 20.4% vs. 白光 7.4% P = 0.083):结论:两组的复发率没有差异。此外,围手术期并发症发生率也不高。
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