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

NCT ID: NCT07208864

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Gastric Intestinal Metaplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

AI-assisted scoring first group

Endoscopists will first evaluate the videos with the assistance of the AI system via EGGIM score, and after the washout period, the videos will be evaluated again without the assistance of the AI system.

Group Type: EXPERIMENTAL

AI-assisted EGGIM scoring

Intervention Type: DIAGNOSTIC_TEST

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

Conventional scoring first group

Endoscopists will first evaluate the videos without the assistance of the AI system via EGGIM score, and after the washout period, the videos will be evaluated again with the assistance of the AI system.

Group Type: ACTIVE_COMPARATOR

Conventional EGGIM scoring

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

AI-assisted EGGIM scoring

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

Intervention Type: DIAGNOSTIC_TEST

Conventional EGGIM scoring

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Zhen Li

Role: CONTACT

qilulizhen@sdu.edu.cn

86+18560086106

Other Identifiers

2025SDU-QILU-4

Identifier Type: -

Identifier Source: org_study_id