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新型内镜蓝激光成像系统检测结直肠肿瘤性病变的多中心随机对照研究。

Detectability of colorectal neoplastic lesions using a novel endoscopic system with blue laser imaging: a multicenter randomized controlled trial.

机构信息

Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.

Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.

出版信息

Gastrointest Endosc. 2017 Aug;86(2):386-394. doi: 10.1016/j.gie.2017.01.017. Epub 2017 Jan 29.

Abstract

BACKGROUND AND AIMS

Most studies have not reported an improvement in the detection of adenomas with the use of image-enhanced colonoscopy methods, possibly because of the darkness of the images. To overcome this limitation, a new-generation endoscopic system has been developed. This system has 2 blue-laser imaging (BLI) observation modes. The BLI observation was set to BLI-bright mode to detect lesions. We aimed to evaluate the efficacy of BLI in detecting lesions.

METHODS

This study was designed as a randomized controlled trial with participants from 8 institutions. We enrolled patients aged ≥40 years. The participants were randomly assigned to 2 groups: observation by using white-light imaging (WLI) with a conventional xenon light source (WLI group) or observation by using BLI-bright mode with a laser light source (BLI group). All of the detected lesions were resected or had a biopsy taken for histopathologic analysis. The primary outcome was the mean number of adenomas per patient (MAP) that were detected per procedure.

RESULTS

The WLI and BLI groups consisted of 474 and 489 patients, respectively. The MAP was significantly higher in the BLI group than in the WLI group (mean ± standard deviation [SD] WLI 1.01 ± 1.36, BLI 1.27 ± 1.73; P = .008). Adenoma detection rate in the BLI group was not significantly higher than in the WLI group. Observation times differed significantly, with BLI (9.48 minutes) being longer than WLI (8.42; P < .001). The mean (± SD) number of polyps per patient was significantly higher in the BLI group compared with the WLI group (WLI 1.43 ± 1.64, BLI 1.84 ± 2.09; P = .001).

CONCLUSIONS

A newly developed system that uses BLI improves the detection of adenomatous lesions compared with WLI. (Clinical trial registration number: UMIN 000014555.).

摘要

背景和目的

大多数研究并未报告使用图像增强结肠镜检查方法可提高腺瘤的检出率,这可能是由于图像较暗所致。为了克服这一局限性,开发了一种新一代内镜系统。该系统具有 2 种蓝激光成像(BLI)观察模式。将 BLI 观察设置为 BLI-明亮模式以检测病变。我们旨在评估 BLI 在检测病变中的效果。

方法

这是一项在 8 家机构的参与者中进行的随机对照试验设计。我们纳入年龄≥40 岁的患者。参与者被随机分为 2 组:使用传统氙光源的白光成像(WLI)观察(WLI 组)或使用激光光源的 BLI-明亮模式观察(BLI 组)。所有检测到的病变均进行切除或活检以进行组织病理学分析。主要结局是每个患者每例手术检测到的平均腺瘤数量(MAP)。

结果

WLI 组和 BLI 组分别纳入了 474 例和 489 例患者。BLI 组的 MAP 显著高于 WLI 组(平均±标准差 WLI 1.01±1.36,BLI 1.27±1.73;P=0.008)。BLI 组的腺瘤检出率并不显著高于 WLI 组。观察时间差异显著,BLI 组(9.48 分钟)长于 WLI 组(8.42 分钟;P<0.001)。BLI 组每个患者的息肉数量显著高于 WLI 组(WLI 1.43±1.64,BLI 1.84±2.09;P=0.001)。

结论

与 WLI 相比,新开发的使用 BLI 的系统可提高腺瘤性病变的检出率。(临床试验注册号:UMIN 000014555。)

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