NCT07757906Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 220 (estimated)
First submitted: 6 Aug 2026
Start date: 7 Aug 2026
Primary completion date: 28 Jul 2027
Lead sponsor: Qilu Hospital of Shandong University
Diseases: Gastric and esophageal cancer
NCT number: NCT07757906

What you commit to

Study type: Interventional
Planned participants: 220
From 7 Aug 2026 to the primary completion date, 28 Jul 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Patients with severe cardiopulmonary disease or other severe comorbidities that may increase the risk of the ESD procedure.
Patients with severe cardiopulmonary disease or other severe comorbidities that may increase the risk of the ESD procedure.

Other

Patients currently undergoing dialysis.
Pregnant or breastfeeding women.
- RCT
Patients currently undergoing dialysis.
Pregnant or breastfeeding women.

Who the study is looking for

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.
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.

Criteria the registry did not label

prospective paired diagnostic study

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
山东大学齐鲁医院 Coordinator of this site? Confirm its status	Jinan	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.