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一项基于个体风险扩大胃癌内镜筛查间隔时间的研究方案:胃癌筛查的前瞻性队列研究

A study protocol for expanding the screening interval of endoscopic screening for gastric cancer based on individual risks: prospective cohort study of gastric cancer screening.

作者信息

Hamashima Chisato, Yoshimura Kenichi, Fukao Akira

机构信息

Health Policy Section, Department of Nursing, Faculty of Medical Technology, Teikyo University, Tokyo, Japan.

Future Medical Center, Hiroshima University Hospital, Hiroshima 734-8551, Japan.

出版信息

Ann Transl Med. 2020 Dec;8(23):1604. doi: 10.21037/atm-20-5949.

DOI:10.21037/atm-20-5949
PMID:33437803
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7791261/
Abstract

BACKGROUND

The Japanese government has recommended a 2-year endoscopic screening interval for gastric cancer. However, insufficient resources have constrained participation in endoscopic screening for gastric cancer. One way to avoid endoscopic screening harms and provide equal access is to define the appropriate screening interval.

METHODS

To expand screening interval from more than 2 years for low-risk group, a single-arm cohort of endoscopic screening started. At the baseline screening, the participants underwent endoscopic screening for gastric cancer, () antibody test, and serum pepsinogen test (first year), and followed after 2 and 4 years (within the first 5 years). We also assessed infection and atrophy status on images of upper gastrointestinal endoscopy at the baseline. A new screening model will be developed by dividing the participants into high-risk and low-risk groups based on demographics, history of eradication, serological testing, and endoscopic diagnosis. The cumulative gastric cancer incidence after negative results at baseline are compared between the low-risk group on the 3rd screening round after 4 years from baseline and the total screening group on the 2nd screening round after 2 years. If the cumulative gastric cancer incidence in the low-risk group on the 3rd screening round is lower than that in the total screening group on the 2nd screening round, the screening interval can be expanded to 4 years in the low-risk group.

DISCUSSION

To reduce mortality from gastric cancer, a high participation rate of the target population is required. The screening interval of endoscopic screening can be changed if the individual risks for infection are clarified. Our goal in this study is to obtain relevant data that can be used to improve the efficient use of endoscopic screening for gastric cancer by referring to individual risks in Japan.

TRIAL REGISTRATION

UMIN000025839 (University Hospital Medical Information Network, Japan).

摘要

背景

日本政府建议胃癌内镜筛查间隔为2年。然而,资源不足限制了胃癌内镜筛查的参与度。避免内镜筛查危害并提供平等机会的一种方法是确定合适的筛查间隔。

方法

为了将低风险组的筛查间隔延长至2年以上,启动了一项内镜筛查单臂队列研究。在基线筛查时,参与者接受了胃癌内镜筛查、()抗体检测和血清胃蛋白酶原检测(第一年),并在2年和4年后(前5年内)进行随访。我们还在基线时评估了上消化道内镜图像上的感染和萎缩状态。将根据人口统计学、根除病史、血清学检测和内镜诊断将参与者分为高风险和低风险组,从而建立一种新的筛查模型。比较基线结果为阴性后,低风险组在基线后4年第3轮筛查时与总筛查组在2年后第2轮筛查时的累积胃癌发病率。如果低风险组在第3轮筛查时的累积胃癌发病率低于总筛查组在第2轮筛查时的发病率,则低风险组的筛查间隔可延长至4年。

讨论

为降低胃癌死亡率,目标人群需要有较高的参与率。如果能明确个体感染风险,内镜筛查的间隔时间可以改变。我们本研究的目标是获得相关数据,以便通过参考日本的个体风险来改善胃癌内镜筛查的有效利用。

试验注册

UMIN000025839(日本大学医院医学信息网络)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cb5/7791261/3c0d9ef943be/atm-08-23-1604-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cb5/7791261/d0173e358a65/atm-08-23-1604-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cb5/7791261/3c0d9ef943be/atm-08-23-1604-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cb5/7791261/d0173e358a65/atm-08-23-1604-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cb5/7791261/3c0d9ef943be/atm-08-23-1604-f2.jpg

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