Kudo Shin-Ei, Takahashi Noriaki, Kodama Kenta, Ishida Fumio, Yamano Hiro-O, Yamamoto Seiichiro, Nagata Koichi, Wakamura Kunihiko, Matsushita Hiro-O, Hiwatashi Nobuo, Matsuda Takahisa, Saito Hiroshi
Digestive Disease Center, Showa Medical University Northern Yokohama Hospital, Yokohama, Japan.
National Cancer Center Institute for Cancer Control, Tokyo, Japan.
BMJ Open Gastroenterol. 2025 May 14;12(1):e001715. doi: 10.1136/bmjgast-2024-001715.
To assess the safety and quality of baseline screening colonoscopy in a randomised controlled trial (RCT).
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.
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%).
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.
UMIN000001980.
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。
一项采用解释性设计的基于人群的RCT正在进行，以评估结肠镜检查筛查对日本9751名年龄在40 - 74岁、患结直肠癌（CRC）平均风险的男性和女性的疗效。干预组的筛查结肠镜检查于2009年6月至2017年6月进行。
干预组的4861名参与者中，4495名（92.5%）接受了筛查结肠镜检查。80.4%的病例肠道准备质量为优（34.8%）或良（45.6%）。盲肠插管率为99.7%（4483/4495），平均（±标准差）退镜时间为9.7（±5.3）分钟。腺瘤检出率（ADR）为39.4%（1770/4495）。共有27名参与者（0.6%）被诊断为CRC，266名（5.9%）被诊断为高级别瘤变（AN）。在女性中，近端结肠腺瘤的检出频率高于远端结肠（近端：18.9%对远端：16.4%，p = 0.024），AN也观察到类似趋势（近端：2.4%对远端：1.5%，p = 0.045）。未报告与筛查结肠镜检查相关的严重不良事件，两名参与者（0.04%）出现轻微不良事件。
在评估筛查结肠镜检查疗效的RCT干预组中，证实了在依从性、ADR和安全性方面的充分表现。试验中观察到的高质量筛查结肠镜检查表明其作为基于人群的筛查方法的可行性。
UMIN000001980。
