The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection (ESD): a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Average single hemostasis time
研究概览
简要总结
The goal of this clinical trial is to learn if an artificial intelligence (AI) system that identifies bleeding points in real time can help stop bleeding faster during endoscopic submucosal dissection (ESD) - a minimally invasive surgery for early digestive tract cancer or precancerous lesions. It will also learn about the AI system's effect on surgery-related problems (like perforation or delayed bleeding) and total surgery time.
The main questions it aims to answer are:
- Does the AI system shorten the time it takes to stop each bleed during ESD?
- How does the AI system affect the rate of surgery-related problems and total surgery time?
Researchers will compare two groups to see if the AI system improves hemostasis efficiency:
- AI group: During ESD, the AI system will real-time spot and mark bleeding points. Doctors will use these marks to stop bleeding.
- Control group: Doctors will use the same equipment but without the AI system - they will find and stop bleeding using their own experience.
Participants will:
- Have ESD surgery for esophageal, stomach, or colorectal lesions that need this treatment;
- Be randomly assigned to either the AI group or the control group;
- Attend follow-up checks in 14 days after surgery to check for complications;
- Have their surgery videos reviewed by experts to record hemostasis time and total surgery time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Aged 18-80 years;
- •Lesions meet the indications for ESD treatment of the esophagus, stomach, or colorectum according to relevant guidelines;
- •Anticoagulant drugs have been suspended according to relevant guidelines;
- •Patients with American Society of Anesthesiologists (ASA) classification Grade I or II;
- •Patients who voluntarily sign the informed consent form.
排除标准
- •Patients with severe cardiopulmonary diseases, coagulation dysfunction or other severe comorbidities that may increase surgical risks;
- •Patients undergoing dialysis treatment;
- •Pregnant or lactating women;
- •Deemed unsuitable for participation in this study by the principal investigator or other researchers.
研究组 & 干预措施
AI-assisted Group
During the endoscopic submucosal dissection (ESD) procedure, an artificial intelligence (AI) real-time bleeding point recognition system is utilized. The system dynamically analyzes endoscopic images to identify and mark bleeding sites in real time. Endoscopists perform hemostatic operations promptly based on these AI-generated markers.
干预措施: AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking (Device)
Conventional treatment group
Patients undergo ESD using the same hardware platform, but the AI system is deactivated. Hemostatic decisions and operations are solely dependent on the endoscopists' clinical experience-they independently judge the location of bleeding points and perform hemostasis without AI assistance.
结局指标
主要结局
Average single hemostasis time
时间窗: Periprocedural
次要结局
- Incidence of postoperative complications(14 days post-procedure)
- Total operation duration(Periprocedural)
- Psychological stress experienced by the endoscopist(Periprocedural)