跳至主要内容
临床试验/NCT05916014
NCT05916014招募中不适用

Artificial Intelligence-assisted White Light Endoscopy to Identify the Kimura-Takemoto Classification of Atrophic Gastritis to Achieve Gastric Cancer Risk Assessment

Shandong University1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Accuracy of AI model to diagnose the Kimura-Takemoto classification

研究概览

简要总结

Grading endoscopic atrophy according to the Kimura-Takemoto classification can assess the risk of gastric neoplasia development. However, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. Therefore, this study aims to develop an AI model to identify the Kimura-Takemoto classification.

详细描述

Grading endoscopic atrophy according to the Kimura-Takemoto classification can assess the risk of gastric neoplasia development. The higher the score, the more severe the degree of atrophic gastritis. However, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. Therefore, this study aims to develop an AI model to identify the Kimura-Takemoto classification of atrophic gastritis to achieve gastric cancer risk assessment.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-80 years who undergo the white light endoscope examination Informed consent form provided by the patient.

排除标准

  • patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric;
  • disorders who cannot participate in gastroscopy;
  • Patients with progressive gastric cancer;
  • low quality pictures;
  • patients with previous surgical procedures on the stomach or esophageal;
  • patients who refuse to sign the informed consent form;

结局指标

主要结局

Accuracy of AI model to diagnose the Kimura-Takemoto classification

时间窗: 2 years

Accuracy of AI model to diagnose the Kimura-Takemoto classification

Specificity of AI model to diagnose the Kimura-Takemoto classification

时间窗: 2 years

Specificity of AI model to diagnose the Kimura-Takemoto classification

Sensitivity of AI model to diagnose the Kimura-Takemoto classification

时间窗: 2 years

Sensitivity of AI model to diagnose the Kimura-Takemoto classification

次要结局

  • The MIOU value of AI model in semantic segmentation of endoscopic atrophy picture(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)

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