Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion

Recruiting

• Conditions: Helicobacter Pylori Infection; Premalignant Lesion

• Registration Number: NCT05762991
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The aim of this diagnostic accuracy study is to evaluate the application of artificial intelligence on the diagnosis of Helicobacter pylori infection and premalignant gastric lesions based on upper endoscopic images. We use techniques of artificial intelligence to analyze the correlation between endoscopic images and urea breath test results/histopathological results.

Detailed Description

This study had invited patients to undergo urea breath test, upper gastrointestinal endoscopy, and histology examination. The study will collect their tests results, upper gastrointestinal endoscopy images, and histopathological results. Artificial intelligence techniques will be used to analyze the correlation between endoscopic images and urea breath test results/histopathological results. We aim to establish a telemedicine system to assist clinicians in diagnosing Helicobacter pylori infection and detecting premalignant gastric lesion using upper endoscopic images. The system will be implemented as a telemedicine service system in the rural areas, for example Matsu Islands. The baseline histological predictions will be linked to the newly incident gastric cancer.

Study Timeline

• Study Start: 2021-12-24
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Age 20-80
2. Scheduled urea breath test and endoscopy

Exclusion Criteria

1. History of gastric surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity to detect premalignant gastric lesions	Up to 5 years	Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection

Secondary Outcome Measures

Name	Time	Method
Specificity to exclude premalignant gastric conditions	Up to 5 years	Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection

Trial Locations

Locations (1)

Yi-Chia Lee; 🇨🇳 Taipei, Taiwan