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临床试验/NCT05452473
NCT05452473Unknown不适用

Clinical Benefit in the CDSS-assisted Screening Upper Gastrointestinal Endoscopy vs. Routine Screening Endoscopy

Chuncheon Sacred Heart Hospital2 个研究点 分布在 2 个国家目标入组 1,200 人开始时间: 2022年7月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
2
主要终点
Gastric lesion detection rate

研究概览

简要总结

This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups.

详细描述

Artificial intelligence has been adopted in the field of gastrointestinal endoscopy. Investigators previously established deep-learning models to predict the histology and invasion depth of gastric lesions using endoscopic stillcut images. However, clinical benefit of this model has not been evaluated. This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients who visited Chuncheon Sacred Heart hospital will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups. Expert endoscopists will conduct this randomized study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Participants who visited for routine screening upper gastrointestinal endoscopy

排除标准

  • Participants who refuse to participate in this study
  • Participants who showed paradoxical reaction prohibiting routine examination

结局指标

主要结局

Gastric lesion detection rate

时间窗: Baseline (gold standard; ground truth is expert endoscopists' lesion detection)

Gastric lesions (low or high grade dysplasia, early gastric cancer, or advanced gastric cancer) detection rate

次要结局

  • Lesion classification accuracy(Baseline (gold standard; ground truth is histologic diagnosis of detected lesions))

研究者

发起方
Chuncheon Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Seok Bang

PI

Chuncheon Sacred Heart Hospital

研究点 (2)

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