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内镜辅助套扎圈结肠切除术与帽辅助结肠切除术在腺瘤检测中的比较:随机串联研究——套扎圈-帽检测试验(DETECT)。

Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy in adenoma detection: randomized tandem study-DEtection in Tandem Endocuff Cap Trial (DETECT).

机构信息

Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK; Department of Surgery and Cancer, Imperial College, London, UK.

Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.

出版信息

Gastrointest Endosc. 2020 Apr;91(4):894-904.e1. doi: 10.1016/j.gie.2019.11.046. Epub 2019 Dec 10.

Abstract

BACKGROUND AND AIMS

Adenoma miss rate during colonoscopy is directly linked to risk of postcolonoscopy colorectal cancer. One of the reasons for missed adenomas is poor visualization of proximal folds during standard colonoscopy withdrawal. Disposable distal attachments such as the plastic cap and Endocuff (Arc Medical Design, Leeds, UK) that hold back folds appear to improve adenoma detection. The primary aim of this study was to compare adenoma detection rates between Endocuff-assisted colonoscopy (EAC) and cap-assisted colonoscopy (CAC).

METHODS

This is a randomized, single-center, tandem colonoscopy trial performed by the same endoscopists on the same day, first with Endocuff Vision (Arc Medical Design, Leeds, UK) followed by cap or vice versa. All procedures were performed by 3 experienced gastroenterology fellows.

RESULTS

One hundred fifty-four patients were recruited. Seventy-eight (50.6%) had CAC as their first procedure. Mean patient age was 61 years (male-to-female ratio, 1:1). Adenoma detection rate was significantly higher for EAC when compared to CAC (53% vs 26%, P = .001). Polyp miss rate was significantly lower in EAC (8.4%) compared with CAC (26.1%, P < .001) as was adenoma miss rate (EAC vs CAC, 6%, vs 19%; P = .002) and diminutive adenoma (<5 mm) miss rate in the EAC group (1.8% vs 19.6%, P < .001). However, there was no significant differences in the miss rates for small adenomas (5-9 mm) (3.7% vs 2.9%, P = .69) or adenomas 10 mm or larger (1.6% vs 2.6%, P = .98 ). The mean number of adenomas per procedure was significantly higher with EAC compared with CAC (1.5 vs .8, P < .001). Cecal intubation time was significantly shorter with EAC than CAC (median 6 vs 7 minutes, P = .01). Conversely, withdrawal time (median 10 vs 8 minutes, P = .01) was significantly longer in EAC.

CONCLUSIONS

This randomized, tandem study demonstrates that EAC has a significantly higher adenoma detection rate and lower adenoma miss rate than CAC. Although insertion times were shorter with EAC, procedures were slightly more uncomfortable, and the cuff had to be removed in a small number of cases. (Clinical trial registration number: NCT03254498.).

摘要

背景与目的

结肠镜检查中腺瘤的遗漏率与结直肠腺瘤癌的风险直接相关。遗漏腺瘤的原因之一是在标准结肠镜检查退出期间近端褶皱的可视化效果不佳。可移动的远端附件,如塑料帽和 Endocuff(Arc Medical Design,英国利兹),可以阻挡褶皱,似乎可以提高腺瘤的检出率。本研究的主要目的是比较 Endocuff 辅助结肠镜检查(EAC)和帽辅助结肠镜检查(CAC)之间的腺瘤检出率。

方法

这是一项由同一位内镜医生在同一天进行的随机、单中心、串联结肠镜研究,首先使用 Endocuff Vision(Arc Medical Design,英国利兹),然后是帽或反之亦然。所有程序均由 3 名经验丰富的胃肠病学研究员进行。

结果

共招募了 154 名患者。78 名(50.6%)首先进行 CAC。平均患者年龄为 61 岁(男女性别比为 1:1)。与 CAC 相比,EAC 的腺瘤检出率显著更高(53%比 26%,P=0.001)。EAC 的息肉遗漏率明显低于 CAC(8.4%比 26.1%,P<0.001),腺瘤遗漏率(EAC 比 CAC,6%比 19%;P=0.002)和 EAC 组微小腺瘤(<5mm)的遗漏率(1.8%比 19.6%,P<0.001)。然而,EAC 组和 CAC 组的小腺瘤(5-9mm)的遗漏率(3.7%比 2.9%,P=0.69)或 10mm 或更大的腺瘤的遗漏率(1.6%比 2.6%,P=0.98)无显著差异。与 CAC 相比,EAC 每例手术的平均腺瘤数量明显更高(1.5 比 0.8,P<0.001)。EAC 的盲肠插管时间明显短于 CAC(中位数 6 比 7 分钟,P=0.01)。相反,EAC 的退出时间(中位数 10 比 8 分钟,P=0.01)明显较长。

结论

这项随机、串联研究表明,EAC 的腺瘤检出率明显高于 CAC,腺瘤遗漏率也较低。尽管 EAC 的插入时间更短,但程序略感不适,而且在少数情况下需要将袖口取下。(临床试验注册号:NCT03254498.)

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