Akita Japan population-based colonoscopy screening trial: report of initial colonoscopy.

IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY

BMJ Open Gastroenterology Pub Date : 2025-05-14 DOI:10.1136/bmjgast-2024-001715

Shin-Ei Kudo, Noriaki Takahashi, Kenta Kodama, Fumio Ishida, Hiro-O Yamano, Seiichiro Yamamoto, Koichi Nagata, Kunihiko Wakamura, Hiro-O Matsushita, Nobuo Hiwatashi, Takahisa Matsuda, Hiroshi Saito

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Abstract

Objective: To assess the safety and quality of baseline screening colonoscopy in a randomised controlled trial (RCT).

Methods: A population-based RCT with an explanatory design is ongoing to evaluate the efficacy of colonoscopy screening in 9751 men and women aged 40-74 years at average risk of colorectal cancer (CRC) in Japan. Screening colonoscopies for the intervention group were performed from June 2009 to June 2017.

Results: Of the 4861 participants in the intervention group, 4495 (92.5%) underwent screening colonoscopy. The quality of bowel preparation was excellent (34.8%) or good (45.6%) in 80.4% of cases. The caecal intubation rate was 99.7% (4483/4495), and the mean (±SD) withdrawal time was 9.7 (±5.3) min. The adenoma detection rate (ADR) was 39.4% (1770/4495). A total of 27 participants (0.6%) were diagnosed with CRC, and 266 (5.9%) were diagnosed with advanced neoplasia (AN). In women, adenomas were more frequently detected in the proximal colon than in the distal colon (proximal: 18.9% vs distal: 16.4%, p=0.024), and a similar trend was observed for AN (proximal: 2.4% vs distal: 1.5%, p=0.045). No serious adverse events related to screening colonoscopy were reported, and minor adverse events were observed in two participants (0.04%).

Conclusions: Adequate performance in compliance, ADR, and safety was confirmed in the intervention arm of the RCT evaluating the efficacy of screening colonoscopy. The high quality of screening colonoscopy observed in the trial suggests its feasibility as a population-based screening approach.

Trial registration number: UMIN000001980.

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日本秋田市人群结肠镜筛查试验：首次结肠镜检查报告。

目的：在一项随机对照试验（RCT）中评估基线筛查结肠镜检查的安全性和质量。方法：一项具有解释设计的基于人群的随机对照试验正在进行中，以评估9751名年龄在40-74岁、结直肠癌（CRC）平均风险的男性和女性结肠镜筛查的疗效。干预组于2009年6月至2017年6月进行结肠镜筛查。结果：干预组4861名参与者中，4495名（92.5%）接受了结肠镜筛查。80.4%的病例肠准备质量为优（34.8%）或良（45.6%）。盲肠插管率为99.7%(4483/4495)，平均（±SD）停药时间为9.7（±5.3）min。腺瘤检出率（ADR）为39.4%（1770/4495）。共有27名参与者（0.6%）被诊断为结直肠癌，266名（5.9%）被诊断为晚期肿瘤（AN）。在女性中，腺瘤在近端结肠比在远端结肠更常见（近端：18.9% vs远端：16.4%,p=0.024），在AN中也观察到类似的趋势（近端：2.4% vs远端：1.5%,p=0.045）。未报告结肠镜筛查相关的严重不良事件，2名参与者（0.04%）观察到轻微不良事件。结论：评价结肠镜筛查疗效的RCT干预组在依从性、不良反应和安全性方面表现良好。在试验中观察到的结肠镜筛查的高质量表明其作为一种基于人群的筛查方法的可行性。试验注册号：UMIN000001980。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMJ Open Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

2 weeks

期刊介绍： BMJ Open Gastroenterology is an online-only, peer-reviewed, open access gastroenterology journal, dedicated to publishing high-quality medical research from all disciplines and therapeutic areas of gastroenterology. It is the open access companion journal of Gut and is co-owned by the British Society of Gastroenterology. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around continuous publication, publishing research online as soon as the article is ready.