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

NCT07757906 — Not applicable, Active not recruiting, 220 participants, Qilu Hospital of Shandong University

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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

Registry	NCT07757906
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	220 (Estimated)
Sponsor	Qilu Hospital of Shandong University (Other)
Conditions	Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia, AI-Based Dissection Trajectory Prediction System
Interventions	AI-based Dissection Trajectory Prediction System (ADTPS), Conventional ESD Procedure (Device)
Dates	start 2026-07-29, primary completion 2027-07-28 (estimated), completion 2027-10-01 (estimated), first posted 2026-08-11, last updated 2026-10-15
Locations	1 site in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Conventional ESD without AI	Active comparator	Device: Conventional ESD Procedure
AI-assisted ESD with ADTPS	Experimental	Device: AI-based Dissection Trajectory Prediction System (ADTPS)

AI-based Dissection Trajectory Prediction System (ADTPS) (Device): 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.
Conventional ESD Procedure (Device): 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.

+Outcome measures

Primary outcomes

NASA-TLX Workload Score [Immediately after the ESD procedure]
Mean Single Dissection Time [During the ESD procedure]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

prospective paired diagnostic study

Inclusion Criteria:

1. Chinese patients aged 18-80 years.
2. 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.
3. No prior treatment for the lesion (including ESD, surgery, radiotherapy, chemotherapy, etc.).
4. Platelet count >100 × 10⁹/L and PT-INR <1.5, with antiplatelet agents (aspirin, clopidogrel, etc.) discontinued for at least 5 days.
5. American Society of Anesthesiologists (ASA) physical status grade I or II.
6. Voluntarily signed informed consent.

Exclusion Criteria:

1. Patients currently undergoing dialysis.
2. Patients with severe cardiopulmonary disease or other severe comorbidities that may increase the risk of the ESD procedure.
3. Pregnant or breastfeeding women.

RCT

Inclusion Criteria:

1. Chinese patients aged 18-80 years.
2. Lesions meeting ESD indications for esophageal, gastric, or colorectal early cancer or high-grade intraepithelial neoplasia, as defined by:

Exclusion Criteria:

+Locations (1)

Facility	City	Country	Status
山东大学齐鲁医院	Jinan, Shandong	China

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