AI-assisted Endoscopic Ultrasound Grading of Early Esophageal Cancer Invasion Depth: A Multicenter, Prospective, Randomized Cohort Study

November 18, 2025 updated by: Wei Liang, Fujian Provincial Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For patients with early esophageal squamous cell carcinoma and precancerous lesions who met the inclusion and exclusion criteria and voluntarily participated in this project, they were randomly divided into the AI group and the conventional group by central randomization, with 100 cases in each group（anticipated）. Randomization method: The personnel responsible for randomization at the center (who do not participate in the inclusion of subjects) log in to the central randomization system to obtain a randomization number, and finally form a randomization allocation table. Blinding implementation: The observation group and control group determined on the random allocation table were marked as A and B respectively, and then the operating physician implemented protocol A or B. Main indicators: Grading judgment of infiltration depth, pathological consistency

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wei Liang, MD
  • Phone Number: +86 -18120888996
  • Email: fjsllw@163.com

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yanqin Xu, MD
        • Sub-Investigator:
          • Jiayao Zheng, MD
      • Putian, Fujian, China, 351100
        • Not yet recruiting
        • Affiliated Hospital of Putian University
        • Contact:
        • Principal Investigator:
          • Huifeng Wu, MD
      • Putian, Fujian, China, 351100
        • Not yet recruiting
        • Putian First Hospital
        • Contact:
        • Principal Investigator:
          • Junwei Xie, MD
        • Sub-Investigator:
          • Linyun Xue, MD
      • Putian, Fujian, China, 351100
        • Not yet recruiting
        • Putian Hospital of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Fangfang Pan, MD
        • Sub-Investigator:
          • Guixiang Yu, MD
      • Putian, Fujian, China, 351100
        • Not yet recruiting
        • Xianyou County General Hospital
        • Contact:
        • Principal Investigator:
          • Huijing Wu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI Group
Use artificial intelligence to assist in the determination of the invasion depth of early esophageal squamous cell carcinoma under endoscopic ultrasound
Device: Artificial Intelligence system
Use artificial intelligence to assist in the determination of the invasion depth of early esophageal squamous cell carcinoma under endoscopic ultrasound
Other Names:
  • Artificial Intelligence
No Intervention: Control group
Routine diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of grading judgment of infiltration depth
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival rate
Time Frame: Three years
3-year survival rate
Three years
Progression Free-Survival
Time Frame: 1 year
The period from the start of treatment to tumor progression or death for any reason
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Provincial Hospital

Investigators

  • Principal Investigator: Wei Liang, MD, Fujian Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2025-02-067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It involves the protection of patent technology

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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