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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Provincial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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