A Single-center, Retrospective, Open Label, Randomized Controlled Trial of Artificial Intelligence Versus Expert Endoscopists for Diagnosis of Gastric Cancer in Patients Who Underwent Upper Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Per patient diagnosis of gastric cancer
研究概览
简要总结
Title: A single-center, retrospective randomized controlled trial of artificial intelligence (AI) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent upper gastrointestinal endoscopy.
Précis: this single-center, retrospective randomized controlled trial will include 500 outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and will compare the diagnostic detection rate for gastric cancer of AI and expert endoscopists.
Objectives Primary Objective: to evaluate the diagnostic detection rate for gastric cancer of AI and expert endoscopists.
Secondary Objectives: to determine whether AI is not inferior to expert endoscopists in terms of the number of images analyzed for diagnosis of gastric cancer and intersection over union (IOU), and the detection rate of diagnosis of early and advanced gastric cancer.
Endpoints Primary Endpoint: diagnosis of gastric cancer. Secondary Endpoints: image based diagnosis of gastric cancer and IOU. Population: in total, 500 males and females aged ≥ 20 years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a single hospital in Japan.
Describe the Intervention: AI-based diagnosis of gastric cancer based on upper gastrointestinal endoscopy images.
Study Duration: 3 months.
详细描述
Prior to Study: Total 500: Screen potential subjects by inclusion and exclusion criteria; obtain endoscopy images.
Randomization was performed.
Intervention: AI diagnosis was performed for 250 patients using upper gastrointestinal endoscopy images, and Expert endoscopists diagnosis was performed for 250 patients by same methods.
Primary analysis: Perform primary analysis of primary and secondary endpoints for 250 patients in each group
Cross over diagnosis between AI and expert endoscopists was performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Males or females aged ≥ 20 years who underwent upper gastrointestinal endoscopy at Tokyo University Hospital during
- •Informed optout consent, obtained from each patient before completion of the study.
排除标准
- •Patients who underwent gastrectomy.
- •Patients who underwent transnasal upper gastrointestinal endoscopy.
结局指标
主要结局
Per patient diagnosis of gastric cancer
时间窗: Up to 6 weeks from study start
Number of Participants
次要结局
- Diagnosis of advanced gastric cancer(Up to 6 weeks from study start)
- Intersection over union (IOU) of gastric lesions(Up to 6 weeks from study start)
- Diagnosis of early gastric cancer(Up to 6 weeks from study start)
- Number of images analyzed for diagnosis of gastric cancer(Up to 6 weeks from study start)
- Agreement on image and IOU based diagnosis of gastric cancer between AI and expert endoscopists(Up to 12 weeks from study start)
研究者
Ryota Niikura
Research Associate
Tokyo University