Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorQilu Hospital of Shandong University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged 40-75 years who undergo the IEE examination
patients who voluntarily sign the informed consent form
Disqualifiers
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
Trial population
Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria will be enrolled into the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
The diagnostic performance of AI system and endoscopists
Diagnostic testEligible patients will undergo independent EGGIM score assessment by both endoscopists and the AI system.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov