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NCT Number: NCT07208864

Efficacy of an AI System in Training Endoscopists to Assess Gastric Intestinal Metaplasia Via the EGGIM Score

This prospective randomized controlled trial with a crossover design incorporated image-enhanced endoscopy (IEE) videos demonstrating complete standardized examinations of five standard gastric areas (antrum greater curvature, antrum lesser curvature, incisura, corpus lesser curvature, and corpus greater curvature). Endoscopists were stratified by experience level and randomly assigned to either the AI-assisted scoring first group, which performed EGGIM scoring with AI assistance in the initial phase followed by conventional scoring after a washout period, or the conventional scoring first group, which completed the assessments in reverse order. The study primarily evaluated the training efficacy of the EGGIM-AI system for improving endoscopists' EGGIM scoring performance by comparing diagnostic accuracy metrics including the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity between groups at different study phases, with histopathological results serving as the gold standard.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Endoscopists who have performed ≥50 image-enhanced endoscopy (IEE) procedures per year and demonstrated competency in performing standardized IEE.

Exclusion criteria

Endoscopists who participated in data acquisition or were unblinded to patients' identifiable information and clinical data.

Treatment and study plan

AI-assisted EGGIM scoring

Diagnostic Test

Endoscopists will evaluate the videos with the assistance of the AI system via EGGIM score.

Conventional EGGIM scoring

Diagnostic Test

Endoscopists will evaluate the videos without the assistance of the AI system via EGGIM score.

Primary outcomes

  1. Efficacy of the EGGIM-AI system for improving endoscopists' EGGIM scoring performance

    Time frame: Through study completion, an average of 3 months

    Diagnostic accuracy metrics including the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity between groups at different study phases, with histopathological results as the gold standard.

Secondary outcomes

  1. Performance of EGGIM scoring by endoscopists with varying experience levels

    Time frame: Through study completion, an average of 3 months

    Differences in AUC, sensitivity, and specificity of EGGIM scores between experienced and inexperienced endoscopists within each group at different phases.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Li

CONTACT

[email protected]

86+18560086106

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Efficacy of an AI System in Training Endoscopists to Assess Gastric Intestinal Metaplasia Via the EGGIM Score: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Dec 5, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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