Clinical trial · Interventional
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AI-Based Dissection Trajectory Prediction System | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| High-Grade Intraepithelial Neoplasia | High Grade Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-based Dissection Trajectory Prediction System (ADTPS) | Device | — | UNRESOLVED |
| Conventional ESD Procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional ESD without AI
- interventionNames
- Device: Conventional ESD Procedure
- type
- EXPERIMENTAL
- label
- AI-assisted ESD with ADTPS
- interventionNames
- Device: AI-based Dissection Trajectory Prediction System (ADTPS)
Primary outcomes (2)
- measure
- NASA-TLX Workload Score
- timeFrame
- Immediately after the ESD procedure
- measure
- Mean Single Dissection Time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
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