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日本全国多中心前瞻性研究:结肠胶囊内镜检查的有效性、安全性及可接受性

Nationwide multicenter prospective study on the usefulness, safety, and acceptability of colon capsule endoscopy in Japan.

作者信息

Hotta Naoki, Ohmiya Naoki, Hiraga Hiroto, Nakaji Konosuke, Osawa Satoshi, Omori Takafumi, Mitsufuji Shoji, Hosoe Naoki, Nouda Sadaharu, Kobayashi Taku, Nakamura Masanao, Oka Shiro, Nonogaki Koji, Baba Yukiko, Mukai Rieko, Matsumoto Hiroshi, Ikebuchi Yuichiro, Shimada Masaaki, Togashi Kazutomo, Katsuki Shinichi, Sasaki Yu, Sawada Ryoichi, Kawano Seiji, Furuta Takahisa, Tajiri Hisao, Tanaka Shinji

机构信息

Department of Internal Medicine, Masuko Memorial Hospital, Nagoya, Japan, Department of Advanced Endoscopy, Fujita Health University School of Medicine, Toyoake, Japan.

Departments of Gastroenterology and Advanced Endoscopy, Fujita Health University School of Medicine, Toyoake, Japan.

出版信息

Gastrointest Endosc. 2025 May;101(5):1051-1063.e7. doi: 10.1016/j.gie.2024.11.004. Epub 2024 Nov 8.

DOI:10.1016/j.gie.2024.11.004
PMID:39521091
Abstract

BACKGROUND AND AIMS

We determined the factors influencing total capsule colonoscopy, adequate cleansing, and detectability of second-generation colon capsule endoscopy (CCE) for colorectal polyps or tumors (CRTs), adverse events, and acceptability.

METHODS

Among 44 Japanese hospitals, 1006 patients with suspected or documented colorectal diseases who underwent CCE were enrolled prospectively.

RESULTS

The total capsule colonoscopy rate was 86.1%. Age younger than 63 years (adjusted odds ratio [aOR], 1.525), male sex (aOR, 1.496), inflammatory bowel disease (aOR, 1.889), lavage intake on day -1 (aOR, 1.625), ≥1800-mL lavage intake on day 0 (aOR, .595), prokinetics on day 0 (aOR, .608), and ≥30-mL castor oil booster on day 0 (aOR, 1.734) were significant independent predictors. The overall adequate cleansing rate was 65.5%. Constipation (aOR, .527), lavage intake on day -1 (aOR, 1.822), laxative intake on day -1 (aOR, 2.616), and ≥1900-mL lavage intake on day 0 (aOR, 1.449) were significant independent predictors. The detection rates for patients with CRTs ≥6 mm and ≥10 mm were 92% (95% confidence interval, 84-97) and 89% (95% confidence interval, 78-96), respectively. Inadequate cleansing in the ascending colon (aOR, .184), ≥6-mm CRT in the transverse colon (aOR, 4.703), and ≥6-mm CRT in the left-sided colon (aOR, 32.013) were significant independent predictors. CCE retention occurred in 2 patients (.20%) requiring endoscopic and surgical interventions. In total, 63% of patients desired CCE for their next colonoscopy.

CONCLUSIONS

CCE was relatively safe, well tolerated, and useful for detecting colorectal lesions when adequate bowel preparation was made. (Clinical trial registration number: UMIN000021936.).

摘要

背景与目的

我们确定了影响第二代结肠胶囊内镜检查(CCE)全结肠检查率、充分肠道准备、结直肠息肉或肿瘤(CRT)的可检测性、不良事件及可接受性的因素。

方法

在44家日本医院中,前瞻性纳入了1006例接受CCE检查的疑似或确诊结直肠疾病患者。

结果

全结肠检查率为86.1%。年龄小于63岁(校正比值比[aOR],1.525)、男性(aOR,1.496)、炎症性肠病(aOR,1.889)、第-1天服用灌洗液(aOR,1.625)、第0天灌洗液摄入量≥1800 mL(aOR,0.595)、第0天使用促动力药(aOR,0.608)以及第0天蓖麻油补充剂≥30 mL(aOR,1.734)是显著的独立预测因素。总体充分肠道准备率为65.5%。便秘(aOR,0.527)、第-1天服用灌洗液(aOR,1.822)、第-1天服用泻药(aOR,2.616)以及第0天灌洗液摄入量≥1900 mL(aOR,1.449)是显著的独立预测因素。CRT≥6 mm和≥10 mm患者的检出率分别为92%(95%置信区间,84-97)和89%(95%置信区间,78-96)。升结肠肠道准备不充分(aOR,0.184)、横结肠CRT≥6 mm(aOR,4.703)以及左侧结肠CRT≥6 mm(aOR,32.013)是显著独立预测因素。2例患者(0.20%)出现CCE滞留,需要内镜和手术干预。总体而言,63%的患者希望下次结肠镜检查时进行CCE。

结论

当进行充分的肠道准备时,CCE相对安全、耐受性良好且有助于检测结直肠病变。(临床试验注册号:UMIN000021936。)

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