Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score

November 27, 2025 updated by: Qilu Hospital of Shandong University

The endoscopic grading system (EGGIM) has been widely used to assess the extent of gastric intestinal metaplasia during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically evaluate the extent of gastric intestinal metaplasia (GIM) and calculate the EGGIM scores in endoscopy examination. This study is a prospective, multi-center study aimed at exploring the performance and reliability of AI-EGGIM scoring.

This is a prospective study designed to validate the AI-EGGIM system in a larger cohort. The study protocol was developed based on preliminary experience from a prior investigation (NCT05464108).

Study Overview

Detailed Description

Gastric intestinal metaplasia (GIM) is an important precancerous stage in the gastric carcinogenesis cascade. The endoscopic grading system (EGGIM) has been proposed as a practical method to evaluate the extent of GIM during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically assess the extent of GIM and calculate EGGIM scores from endoscopic examinations. This study is a prospective, multi-center study aimed at evaluating the accuracy, performance, and reliability of AI-assisted EGGIM scoring.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

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

Study Locations

    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong First Medical University First Affiliated Hospital
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Second Provincial General Hospital

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria will be enrolled into the study.

Description

Inclusion Criteria:

  • patients aged 40-75 years who undergo the IEE examination
  • patients who voluntarily sign the informed consent form

Exclusion Criteria:

  • patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
  • patients with previous surgical procedures on the stomach

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of AI system to diagnose the grade of intestinal metaplasia by calculating the EGGIM score
Time Frame: 1 year
The performance of the AI system will be evaluated in diagnosing the grade of gastric intestinal metaplasia (IM) based on the Endoscopic Grading of Gastric Intestinal Metaplasia (EGGIM) system. EGGIM is a validated scoring method ranging from 0 to 10, reflecting the extent of IM across five gastric regions: two in the antrum, two in the corpus, and one at the incisura. Each region is scored as 0 (no IM), 1 (focal IM, ≤30% of the area), or 2 (extensive IM, >30% of the area), with a total possible score of 10. Higher EGGIM scores correspond to more severe IM and greater gastric cancer risk. The AI-derived scores will be compared with expert' EGGIM scores, which serve as the gold standard, to assess diagnostic accuracy.
1 year

Collaborators and Investigators

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

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 (Actual)

November 1, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 28, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2025SDU-QILU-5

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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