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新型远端附件辅助结肠镜检查提高腺瘤检出率:一项前瞻性随机对照试验。

Improved adenoma detection by a novel distal attachment device-assisted colonoscopy: a prospective randomized controlled trial.

机构信息

Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea; Digestive Diseases Research Center, University of Ulsan College of Medicine, Seoul, South Korea.

Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.

出版信息

Gastrointest Endosc. 2022 Sep;96(3):543-552.e1. doi: 10.1016/j.gie.2022.04.1307. Epub 2022 Apr 30.

DOI:10.1016/j.gie.2022.04.1307
PMID:35500658
Abstract

BACKGROUND AND AIMS

WingCap (A&A Medical Supply LLC, Seongnam, South Korea) is a novel distal attachment device for colonoscopy that combines a cap and an existing mucosal exposure device, such as Endocuff Vision (Arc Medical Design Ltd, Leeds, UK) and AmplifEYE (Medivators Inc, Minneapolis, Minn, USA). We aimed to investigate whether WingCap-assisted colonoscopy can improve the adenoma detection rate (ADR) and adenoma per colonoscopy (APC) and simultaneously shorten cecal intubation time compared with standard colonoscopy.

METHODS

We conducted a single-center, prospective, randomized controlled trial for outpatients aged ≥18 years undergoing colonoscopy. The primary outcome was ADR differences with the assistance of WingCap. Secondary outcomes were APC and other colonoscopy quality indicators, such as cecal intubation and withdrawal times.

RESULTS

In total, 537 patients were randomized for WingCap-assisted or standard colonoscopy. Their mean age was 59.3 years, and 48.5% were men. ADR was significantly higher in the WingCap group than in the control group (37.2% vs 26.6%, P = .012). APC was greater with WingCap than with standard colonoscopy (.72 ± 1.34 vs .45 ± 0.97, P = .008), prominently for nonpedunculated (.65 ± 1.25 vs .42 ± .95, P = .015) and diminutive (.42 ± .94 vs .20 ± .64, P = .002) adenomas. With WingCap, ADR and APC significantly increased for beginner endoscopists, whereas a modest increase was seen for experienced endoscopists. There were no differences in cecal intubation and withdrawal times between the 2 arms. No serious adverse event was associated with the use of WingCap.

CONCLUSIONS

WingCap-assisted colonoscopy was tolerable and efficacious for improving ADR and APC compared with standard colonoscopy, especially for nonpedunculated and diminutive adenomas and for beginner endoscopists. (Clinical trial registration number: KCT0005214.).

摘要

背景和目的

WingCap(韩国城南市 A&A Medical Supply LLC)是一种新型的结肠镜远端附件装置,它结合了一个帽和现有的黏膜暴露装置,如 Endocuff Vision(英国 Leeds 的 Arc Medical Design Ltd)和 AmplifEYE(美国明尼苏达州 Minneapolis 的 Medivators Inc)。我们旨在研究 WingCap 辅助结肠镜检查是否可以提高腺瘤检出率(ADR)和每例结肠镜检查的腺瘤数(APC),同时与标准结肠镜检查相比缩短盲肠插管时间。

方法

我们进行了一项单中心、前瞻性、随机对照试验,纳入年龄≥18 岁的行结肠镜检查的门诊患者。主要结局是 WingCap 辅助下的 ADR 差异。次要结局是 APC 和其他结肠镜质量指标,如盲肠插管和退出时间。

结果

共有 537 例患者被随机分为 WingCap 辅助组或标准组行结肠镜检查。他们的平均年龄为 59.3 岁,48.5%为男性。WingCap 组的 ADR 明显高于对照组(37.2%比 26.6%,P=.012)。WingCap 组的 APC 大于标准组(.72±1.34 比.45±0.97,P=.008),尤其是无蒂(.65±1.25 比.42±.95,P=.015)和微小(.42±0.94 比.20±0.64,P=.002)腺瘤。对于初学者,WingCap 辅助检查的 ADR 和 APC 显著增加,而对于经验丰富的内镜医生则略有增加。两组的盲肠插管和退出时间无差异。使用 WingCap 没有与严重不良事件相关。

结论

与标准结肠镜检查相比,WingCap 辅助结肠镜检查可耐受且有效,可提高 ADR 和 APC,尤其是无蒂和微小腺瘤,以及初学者。(临床试验注册号:KCT0005214。)

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