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使用内镜套辅助结肠镜检查提高腺瘤检出率——一项随机对照多中心试验

Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial.

作者信息

Floer Martin, Biecker Erwin, Fitzlaff Rüdiger, Röming Hermann, Ameis Detlev, Heinecke Achim, Kunsch Steffen, Ellenrieder Volker, Ströbel Philipp, Schepke Michael, Meister Tobias

机构信息

Departments of Gastroenterology, HELIOS Albert-Schweitzer-Hospital Northeim, Northeim, Germany.

HELIOS Medical Center Siegburg, Siegburg, Germany; Department of Gastroenterology, Zollernalb Medical Center, Bailingen, Germany.

出版信息

PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.

Abstract

OBJECTIVES

The Endocuff is a device mounted on the tip of the colonoscope to help flatten the colonic folds during withdrawal. This study aimed to compare the adenoma detection rates between Endocuff-assisted (EC) colonoscopy and standard colonoscopy (SC).

METHODS

This randomized prospective multicenter trial was conducted at four academic endoscopy units in Germany.

PARTICIPANTS

500 patients (235 males, median age 64[IQR 54-73]) for colon adenoma detection purposes were included in the study. All patients were either allocated to EC or SC. The primary outcome measure was the determination of the adenoma detection rates (ADR).

RESULTS

The ADR significantly increased with the use of the Endocuff compared to standard colonoscopy (35.4%[95% confidence interval{CI} 29-41%] vs. 20.7%[95%CI 15-26%], p<0.0001). Significantly more sessile polyps were detected by EC. Overall procedure time and withdrawal time did not differ. Caecal and ileum intubation rates were similar. No major adverse events occurred in both groups. In multivariate analysis, age (odds ratio [OR] 1.03; 95%[CI] 1.01-1.05), male sex (OR 1.74; 95%CI 1.10-2.73), withdrawal time (OR 1.16; 95%CI 1.05-1.30), procedure time (OR 1.07; 95%CI 1.04-1.10), colon cleanliness (OR 0.60; 95%CI 0.39-0.94) and use of Endocuff (OR 2.09; 95%CI 1.34-3.27) were independent predictors of adenoma detection rates.

CONCLUSIONS

EC increases the adenoma detection rate by 14.7%(95%CI 6.9-22.5%). EC is safe, effective, easy to handle and might reduce colorectal interval carcinomas.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02034929.

摘要

目的

Endocuff是一种安装在结肠镜顶端的装置,用于在退镜过程中帮助展平结肠皱襞。本研究旨在比较Endocuff辅助结肠镜检查(EC)和标准结肠镜检查(SC)之间的腺瘤检出率。

方法

这项随机前瞻性多中心试验在德国的四个学术性内镜检查单位进行。

参与者

500例以检测结肠腺瘤为目的的患者(235例男性,中位年龄64岁[四分位间距54 - 73岁])纳入本研究。所有患者均被分配至EC组或SC组。主要结局指标是确定腺瘤检出率(ADR)。

结果

与标准结肠镜检查相比,使用Endocuff时ADR显著增加(35.4%[95%置信区间{CI} 29 - 41%] 对 20.7%[95%CI 15 - 26%],p<0.0001)。EC检测到的无蒂息肉显著更多。总体操作时间和退镜时间无差异。盲肠和回肠插管率相似。两组均未发生重大不良事件。在多变量分析中,年龄(比值比[OR] 1.03;95%[CI] 1.01 - 1.05)、男性(OR 1.74;95%CI 1.10 - 2.73)、退镜时间(OR 1.16;95%CI 1.05 - 1.30)、操作时间(OR 1.07;95%CI 1.04 - 1.10)、结肠清洁度(OR 0.60;95%CI 0.39 - 0.94)以及使用Endocuff(OR 2.09;95%CI 1.34 - 3.27)是腺瘤检出率的独立预测因素。

结论

EC使腺瘤检出率提高了14.7%(95%CI 6.9 - 22.5%)。EC安全、有效、易于操作,可能会减少结直肠癌间隔期癌。

试验注册

ClinicalTrials.gov NCT02034929。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef77/4255000/d6f20dc860f3/pone.0114267.g001.jpg

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