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NCT Number: NCT07257796

Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score

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).

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University, Jinan, Shandong, China

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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