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

Official record

Identifier

NCT07757906

Recruiting locations

country

China

Interventions studied

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

Lead sponsor

Qilu Hospital of Shandong University

Target enrolment

220 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Active, not recruiting

First posted

Aug 11, 2026

Last updated on the registry

Sep 24, 2026

Age

18 Years – 80 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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 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.

Indexed under

Esophageal Cancer