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

Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion: A Multihospital Study

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection; Premalignant Lesion

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Tsung-Hsien Chiang, MD,PhD; Phone Number: 265427 886-2-23123456; Email: thchiang@ntu.edu.tw
• Study Contact Backup: Name: Yi-Chia Lee, MD, PhD; Phone Number: 265689 886-2-23123456; Email: yichialee@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10015
    • Recruiting
    • Yi-Chia Lee
    • Contact: Yi-Chia Lee; Email: yichialee@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will invite patients who need to undergo urea breath test, upper gastrointestinal endoscopy and histology examination.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. History of gastric surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Helicobacter pylori infection and premalignant gastric lesion; Application of artificial intelligence to analyze the correlation between endoscopic images and urea breath test results/histopathological results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity to detect premalignant gastric lesions	Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity to exclude premalignant gastric conditions	Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection	Up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Areas under the ROC curves	Outcomes include the atrophic gastritis, intestinal metaplasia, and Helicobacter pylori infection	Up to 5 years
Gastric cancer incidence	New incident gastric cancer	Up to 10 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Tsung-Hsien Chiang, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Helicobacter, Artificial Intelligence, Telemedicine
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Precancerous Conditions
• Other Study ID Numbers: 202111108RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study was based on the images and histological data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No