跳至主要内容
临床试验/NCT06585553
NCT06585553已完成不适用

Patients with Intestinal Metaplasia in the Lesser Curvature of the Gastric Corpus Require OLGIM Staging: a Secondary Analysis of a Prospective Cohort

Shandong University1 个研究点 分布在 1 个国家目标入组 2,121 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,121
试验地点
1
主要终点
Diagnostic Performance of IM at Different Sites

研究概览

简要总结

Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Baseline information such as height, weight, age, sex, smoking and alcohol consumption status, HP status, and family history of gastrointestinal tumors were recorded before endoscopy. During endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the Kimura-Takemoto classification, and classified those with a Kimura-Takemoto score of C0 as non-atrophic gastritis and those with C1-O3 as atrophic gastritis. Patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected IM areas and random biopsies from Sydney classification sites. At least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and OLGIM staging was calculated based on the results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria were patients aged 40-75 undergoing painless screening endoscopy

排除标准

  • previous gastric surgery; 2) inability to undergo biopsy due to anticoagulant use; 3) refusal to sign informed consent; 4) history of radiotherapy or chemotherapy; 5) new diagnosis of advanced gastric cancer during endoscopy; 6) failure to complete multiple-site biopsy for atrophic gastritis; and 7) diagnosis of non-atrophic gastritis during endoscopy.

结局指标

主要结局

Diagnostic Performance of IM at Different Sites

时间窗: 3 years

Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of IM at different gastric sites for predicting OLGIM stage III/IV were calculated.

次要结局

未报告次要终点

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanqing Li

professor

Shandong University

研究点 (1)

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