Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection: A Prospective Paired Diagnostic Study and a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- NASA-TLX Workload Score
研究概览
简要总结
In this prospective paired diagnostic study and single-center, randomized controlled trial, patients with early esophageal squamous neoplasia or high-grade intraepithelial neoplasia meeting the inclusion and exclusion criteria will be enrolled in a paired diagnostic cohort (60 patients) and subsequently randomly assigned (1:1) to receive endoscopic submucosal dissection (ESD) with AI-based Dissection Trajectory Prediction System (ADTPS) guidance or conventional ESD (without AI). Clinical data and operator workload scores (NASA-TLX) are collected during the procedure, and postoperative follow-up assessments are performed at days 1, 3, 7, and 14. The study aims to analyze the impact of ADTPS on the mean single-dissection time and operator workload in patients undergoing ESD by comparing the efficacy differences between the experimental and control groups. Additionally, the study investigates the effects of ADTPS on other postoperative complications including R0 resection rate, muscularis propria injury, intraoperative bleeding, perforation (acute and delayed), and total procedure time; conducts a comparative analysis of the safety and efficiency of AI-assisted versus conventional ESD; and develops effective clinical strategies for optimizing dissection trajectory and reducing complications in endoscopic submucosal dissection.
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
- Double (Participant, Care Provider)
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
- •Chinese patients aged 18-80 years.
- •Lesions meeting ESD indications for esophageal, gastric, or colorectal early cancer or high-grade intraepithelial neoplasia, as defined by:
- •Non-invasive tumors regardless of size; or
- •Differentiated-type intramucosal carcinoma without ulceration, regardless of size; or
- •Differentiated-type intramucosal carcinoma with ulceration and a diameter ≤3 cm; or
- •Undifferentiated-type intramucosal carcinoma without ulceration and a diameter ≤2 cm.
- •Planned to undergo ESD treatment.
- •No prior treatment for the lesion (including ESD, surgery, radiotherapy, chemotherapy, etc.).
- •Platelet count >100 × 10⁹/L and PT-INR <1.5, with antiplatelet agents (aspirin, clopidogrel, etc.) discontinued for at least 5 days.
- •American Society of Anesthesiologists (ASA) physical status grade I or II.
- •Voluntarily signed informed consent.
排除标准
- •Patients currently undergoing dialysis.
- •Patients with severe cardiopulmonary disease or other severe comorbidities that may increase the risk of the ESD procedure.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
AI-assisted ESD with ADTPS
干预措施: AI-based Dissection Trajectory Prediction System (ADTPS) (Device)
Conventional ESD without AI
干预措施: Conventional ESD Procedure (Device)
结局指标
主要结局
NASA-TLX Workload Score
时间窗: Immediately after the ESD procedure
Mean Single Dissection Time
时间窗: During the ESD procedure
次要结局
- R0 Resection Rate(At the time of pathological examination)
- Muscularis Propria Injury Rate(During the ESD procedure)
- Intraoperative Bleeding Episodes(During the ESD procedure)
- Intraoperative Perforation Rate(During the ESD procedure)
- Delayed Bleeding Rate(Within 14 days after procedure)
- Delayed Perforation Rate(Within 14 days after procedure)
- Total Procedure Time(During the ESD procedure)