AI-assisted Endoscopic Ultrasound Grading of Early Esophageal Cancer Invasion Depth: A Multicenter, Prospective, Randomized Cohort Study
1 other identifier
interventional
200
1 country
5
Brief Summary
This study mainly uses an artificial intelligence system to assist in the classification of the depth of invasion of early esophageal squamous cell carcinoma under ultrasound endoscopy, providing a basis for preoperative T staging and diagnosis and treatment decisions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedStudy Start
First participant enrolled
November 20, 2025
CompletedFirst Posted
Study publicly available on registry
November 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
November 26, 2025
November 1, 2025
1.9 years
November 14, 2025
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The accuracy of grading judgment of infiltration depth
By comparing with the postoperative pathology, the accuracy of the preoperative T grading with the assistance of the artificial intelligence grading system was verified
2 years
Secondary Outcomes (2)
survival rate
Three years
Progression Free-Survival
1 year
Study Arms (2)
AI Group
EXPERIMENTALUse artificial intelligence to assist in the determination of the invasion depth of early esophageal squamous cell carcinoma under endoscopic ultrasound
Control group
NO INTERVENTIONRoutine diagnosis
Interventions
Use artificial intelligence to assist in the determination of the invasion depth of early esophageal squamous cell carcinoma under endoscopic ultrasound
Eligibility Criteria
You may qualify if:
- Satisfy ①⑧⑨ and one of the following conditions simultaneously: ②③④⑤⑥⑦ ① Age over 18 years old, ② Esophageal ulcer, ③ low-grade intraepithelial neoplasia, ④ high-grade intraepithelial neoplasia, ⑤ patients with esophageal squamous cell carcinoma, ⑥ white patches of esophageal mucosa, ⑦ esophageal polyps, ⑧ with endoscopic examination records and detailed pathological records, ⑨ agree to participate in the study;
You may not qualify if:
- ① Patients who have undergone esophageal cancer surgery, ② those with a history of radiotherapy and chemotherapy for esophageal cancer, ③ patients with missing data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Fujian provincial hospital
Fuzhou, Fujian, 350001, China
Affiliated Hospital of Putian University
Putian, Fujian, 351100, China
Putian First Hospital
Putian, Fujian, 351100, China
Putian Hospital of Traditional Chinese Medicine
Putian, Fujian, 351100, China
Xianyou County General Hospital
Putian, Fujian, 351100, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Liang, MD
Fujian Provincial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Digestive Endoscopy Center
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 26, 2025
Study Start
November 20, 2025
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
It involves the protection of patent technology