跳至主要内容
临床试验/NCT05464108
NCT05464108已完成不适用

Validation the Artificial Intelligence System for Automatic Evaluation of the Extent of

Shandong University1 个研究点 分布在 1 个国家目标入组 1,080 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
1,080
试验地点
1
主要终点
Accuracy of AI model to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score

研究概览

简要总结

The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. But its clinical application is limited for at least biopsy samples. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. The investigators designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.

详细描述

Gastric intestinal metaplasia(GIM) is an important stage in the gastric cancer(GC). The operative link on gastric intestinal metaplasia assessment (OLGIM) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. However, its need to take at least 4 biopsies is not clinically feasible. The endoscopic grading system (EGGIM) has been shown a significant correlation with the OLGIM. An EGGIM score of 5 was the best cut off value for identifying OLGIM stage III/IV patients. The investigators have designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of IM and calculate the EGGIM scores in endoscopy examination. This study is aimed at exploring the relevance of the EGGIM scores automatically evaluated by Artificial Intelligence and OLGIM scores.

研究设计

研究类型
Observational
观察模型
Other
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

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
  • patients with contraindications to biopsy
  • patients who refuse to sign the informed consent form

结局指标

主要结局

Accuracy of AI model to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score

时间窗: 2 years

A scale for endoscopic grading of gastric intestinal metaplasia (EGGIM) varies from 0 (normal endoscopy with no areas suggestive of intestinal metaplasia) to 10 (diffuse metaplasia in all gastric areas). Five different areas were considered (two areas in the antrum, two in the corpus, and one in the incisura). Each area was scored 0 (no intestinal metaplasia), 1 (focal intestinal metaplasia, ≤30 % of the area), or 2 points (extensive intestinal metaplasia in that area, \> 30 % of the area), giving a possible total of 10 points. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients.

次要结局

  • Accuracy of experienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score(2 years)
  • Inter-observer agreement among inexperienced endoscopists in identifying the EGGIM scores(2 years)
  • Inter-observer agreement among experienced endoscopists in identifying the EGGIM scores(2 years)
  • Accuracy of inexperienced endoscopists to diagnose extensive intestinal metaplasia (OLGIM stage III/IV) by calculating the EGGIM score(2 years)

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

Vice President of Qilu Hospital

Shandong University

研究点 (1)

Loading locations...

相似试验

Validation the Artificial Intelligence System for... | 临床试验