Clinical Benefit in the CDSS-assisted Screening Upper Gastrointestinal Endoscopy vs. Routine Screening Endoscopy
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
- 是
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
Chang Seok Bang
PI
Chuncheon Sacred Heart Hospital
