Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score

NCT07257796 | Recruiting

• 1 other identifier: 2025SDU-QILU-5
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Intestinal Metaplasia of Gastric Mucosa; Artificial Intelligence; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Performance of AI system to diagnose the grade of intestinal metaplasia by calculating the EGGIM score

  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

Interventions

The diagnostic performance of AI system and endoscopists DIAGNOSTIC_TEST

Eligible patients will undergo independent EGGIM score assessment by both endoscopists and the AI system.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (3)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Shandong First Medical University First Affiliated Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Shandong Second Provincial General Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 2, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-09

Locations

CN (3)