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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 3 words
  2. Minor Enrollment increased: 160 → 220 participants
    • Eligibility criteria expanded, about 157 words
  3. Minor Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 2 words
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07757906
Lead Sponsor Qilu Hospital of Shandong University
Conditions
(from sponsor)
Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia, AI-Based Dissection Trajectory Prediction System
Related terms Esophageal Squamous Cell Carcinoma
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov