Clinical Research on Navigation and Quality Control System of Mediastinal Ultrasound Endoscopy Based on Deep Learning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
The goal of this clinical trial is to develop and verify the auxiliary role of the artificial intelligence system in mediastinal ultrasound endoscopic scanning. The main questions it aims to answer are as follows: 1.The comparison of the image recognition accuracy between the artificial intelligence system and the ultrasound endoscopist; 2. Whether the artificial intelligence system can improve the integrity and efficiency of the mediastinum scanning for the ultrasound endoscopist. Participants will undergo mediastinal EUS with or without the assistance of the artificial intelligence system.
详细描述
In this study, a total of 200 cases of mediastinal endoscopic ultrasound scanning videos will be collected. First of all, an artificial intelligence system based on deep learning for the navigation and quality control of mediastinal endoscopic ultrasonography will be established. Secondly, the artificial intelligence system will be used to identify the site and anatomical structure of the mediastinal ultrasound endoscope, and the results of the artificial intelligence system's station recognition will be compared with the results of the endoscopist's station recognition. Finally, the completeness of standard sites and scanning time of endoscopic-assisted and non-assisted AI systems were compared.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •Age ≥18 years old, <80 years old 2.Patients who need endoscopic ultrasonography;
- •Agree to participate in this study and sign the informed consent form.
排除标准
- •Subjects who meet any of the following criteria cannot be selected for this trial:
- •First. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography:
- •Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
- •Anesthesia assessment failed
- •Pregnancy or breastfeeding
- •In the acute stage of chemical and corrosive injury, it is very easy to cause perforation
- •Recent acute coronary syndrome or clinically unstable ischemic heart attack
- •Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure> 90mmHg),patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.
- •Second. Disagree to participate in this study.
- •Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:
- •Mediastinal lesions have previously undergone surgery or radiotherapy and chemotherapy;
- •Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.
结局指标
主要结局
Accuracy
时间窗: 1 year
The number of correctly classified images divided by the total number of images.
The completeness for standard station scanning
时间窗: Until the end of the study
This was calculated as the number of stations successfully scanned divided by the total number of stations that should have been scanned.
次要结局
- The incidence of adverse events(Until the end of the study)
- Cohen's kappa coefficient(1 year)
- The completeness for standard stations and anatomical landmarks per individual(Until the end of the study)
- The completeness of anatomical landmarks(Until the end of the study)
- Operation time(Until the end of the study)