跳至主要内容
临床试验/NCT07257796
NCT07257796招募中不适用

Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score

Qilu Hospital of Shandong University3 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
3
主要终点
Performance of AI system to diagnose the grade of intestinal metaplasia by calculating the EGGIM score

研究概览

简要总结

The endoscopic grading system (EGGIM) has been widely used to assess the extent of gastric intestinal metaplasia during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically evaluate the extent of gastric intestinal metaplasia (GIM) and calculate the EGGIM scores in endoscopy examination. This study is a prospective, multi-center study aimed at exploring the performance and reliability of AI-EGGIM scoring.

This is a prospective study designed to validate the AI-EGGIM system in a larger cohort. The study protocol was developed based on preliminary experience from a prior investigation (NCT05464108).

详细描述

Gastric intestinal metaplasia (GIM) is an important precancerous stage in the gastric carcinogenesis cascade. The endoscopic grading system (EGGIM) has been proposed as a practical method to evaluate the extent of GIM during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically assess the extent of GIM and calculate EGGIM scores from endoscopic examinations. This study is a prospective, multi-center study aimed at evaluating the accuracy, performance, and reliability of AI-assisted EGGIM scoring.

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

  • patients aged 40-75 years who undergo the IEE examination
  • patients who voluntarily sign the informed consent form

排除标准

  • patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
  • patients with previous surgical procedures on the stomach

结局指标

主要结局

Performance of AI system to diagnose the grade of intestinal metaplasia by calculating the EGGIM score

时间窗: 1 year

The performance of the AI system will be evaluated in diagnosing the grade of gastric intestinal metaplasia (IM) based on the Endoscopic Grading of Gastric Intestinal Metaplasia (EGGIM) system. EGGIM is a validated scoring method ranging from 0 to 10, reflecting the extent of IM across five gastric regions: two in the antrum, two in the corpus, and one at the incisura. Each region is scored as 0 (no IM), 1 (focal IM, ≤30% of the area), or 2 (extensive IM, \>30% of the area), with a total possible score of 10. Higher EGGIM scores correspond to more severe IM and greater gastric cancer risk. The AI-derived scores will be compared with expert' EGGIM scores, which serve as the gold standard, to assess diagnostic accuracy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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