Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection
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
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Shandong
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Jinan、Shandong、中国、250012
- 山东大学齐鲁医院
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Conventional ESD without AI
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The same endoscopic hardware platform is used, but the AI-based Dissection Trajectory Prediction System (ADTPS) is turned off.
The endoscopist performs the ESD procedure based solely on clinical judgment and personal experience, following standard conventional ESD steps including marking, injection, circumferential incision, and submucosal dissection.
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实验性的:AI-assisted ESD with ADTPS
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The ADTPS is an artificial intelligence software system that analyzes endoscopic images in real time during ESD.
It automatically identifies lesion boundaries and generates a recommended dissection trajectory overlaid on the endoscopic view.
The endoscopist follows the AI-generated trajectory to perform submucosal dissection.
The system provides visual guidance only and does not alter the standard surgical workflow.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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NASA-TLX Workload Score
大体时间:Immediately after the ESD procedure
|
Immediately after the ESD procedure
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Mean Single Dissection Time
大体时间:During the ESD procedure
|
During the ESD procedure
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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R0 Resection Rate
大体时间:At the time of pathological examination
|
At the time of pathological examination
|
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Muscularis Propria Injury Rate
大体时间:During the ESD procedure
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During the ESD procedure
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Intraoperative Bleeding Episodes
大体时间:During the ESD procedure
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During the ESD procedure
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Intraoperative Perforation Rate
大体时间:During the ESD procedure
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During the ESD procedure
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Delayed Bleeding Rate
大体时间:Within 14 days after procedure
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Within 14 days after procedure
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Delayed Perforation Rate
大体时间:Within 14 days after procedure
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Within 14 days after procedure
|
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Total Procedure Time
大体时间:During the ESD procedure
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During the ESD procedure
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026SDU-QILU-4
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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