AI-assisted Endoscopic Ultrasound Grading of Early Esophageal Cancer Invasion Depth: A Multicenter, Prospective, Randomized Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The accuracy of grading judgment of infiltration depth
研究概览
简要总结
This study mainly uses an artificial intelligence system to assist in the classification of the depth of invasion of early esophageal squamous cell carcinoma under ultrasound endoscopy, providing a basis for preoperative T staging and diagnosis and treatment decisions.
详细描述
For patients with early esophageal squamous cell carcinoma and precancerous lesions who met the inclusion and exclusion criteria and voluntarily participated in this project, they were randomly divided into the AI group and the conventional group by central randomization, with 100 cases in each group（anticipated）. Randomization method: The personnel responsible for randomization at the center (who do not participate in the inclusion of subjects) log in to the central randomization system to obtain a randomization number, and finally form a randomization allocation table. Blinding implementation: The observation group and control group determined on the random allocation table were marked as A and B respectively, and then the operating physician implemented protocol A or B. Main indicators: Grading judgment of infiltration depth, pathological consistency
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Satisfy ①⑧⑨ and one of the following conditions simultaneously: ②③④⑤⑥⑦ ① Age over 18 years old, ② Esophageal ulcer, ③ low-grade intraepithelial neoplasia, ④ high-grade intraepithelial neoplasia, ⑤ patients with esophageal squamous cell carcinoma, ⑥ white patches of esophageal mucosa, ⑦ esophageal polyps, ⑧ with endoscopic examination records and detailed pathological records, ⑨ agree to participate in the study;
排除标准
- •① Patients who have undergone esophageal cancer surgery, ② those with a history of radiotherapy and chemotherapy for esophageal cancer, ③ patients with missing data.
结局指标
主要结局
The accuracy of grading judgment of infiltration depth
时间窗: 2 years
By comparing with the postoperative pathology, the accuracy of the preoperative T grading with the assistance of the artificial intelligence grading system was verified
次要结局
- survival rate(Three years)
- Progression Free-Survival(1 year)
研究者
Wei Liang
Digestive Endoscopy Center
Fujian Provincial Hospital