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Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection

2026年9月16日 更新者:Qilu Hospital of Shandong University

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

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.

研究概览

研究类型

介入性

注册 (估计的)

160

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shandong
      • Jinan、Shandong、中国、250012
        • 山东大学齐鲁医院

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
有源比较器:Conventional ESD without AI
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.
实验性的:AI-assisted ESD with ADTPS
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.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
NASA-TLX Workload Score
大体时间:Immediately after the ESD procedure
Immediately after the ESD procedure
Mean Single Dissection Time
大体时间:During the ESD procedure
During the ESD procedure

次要结果测量

结果测量
大体时间
R0 Resection Rate
大体时间:At the time of pathological examination
At the time of pathological examination
Muscularis Propria Injury Rate
大体时间:During the ESD procedure
During the ESD procedure
Intraoperative Bleeding Episodes
大体时间:During the ESD procedure
During the ESD procedure
Intraoperative Perforation Rate
大体时间:During the ESD procedure
During the ESD procedure
Delayed Bleeding Rate
大体时间:Within 14 days after procedure
Within 14 days after procedure
Delayed Perforation Rate
大体时间:Within 14 days after procedure
Within 14 days after procedure
Total Procedure Time
大体时间:During the ESD procedure
During the ESD procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月29日

初级完成 (估计的)

2027年7月28日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年8月6日

首先提交符合 QC 标准的

2026年8月6日

首次发布 (实际的)

2026年8月11日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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