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

NCT05762991 | Recruiting DMC

• 1 other identifier: 202111108RINC
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the impact of artificial intelligence (AI) assistance during routine upper endoscopy on gastric cancer-specific mortality. We hypothesize that AI-assisted endoscopic interpretation can further reduce gastric cancer-related mortality through two mechanisms: (1) improved detection of H. pylori infection, facilitating timely eradication therapy and subsequent prevention of gastric carcinogenesis; and (2) earlier identification of premalignant gastric conditions, enabling appropriate surveillance endoscopy and earlier detection of gastric cancer. The primary endpoint is gastric cancer-specific mortality.

Conditions

Helicobacter Pylori Infection; Premalignant Lesion

Outcome Measures

Primary Outcomes (1)

• Gastric cancer-specific mortality

  The primary endpoint is gastric cancer-specific mortality.

  Up to 5 years

Study Arms (2)

Routine endoscopy alone

Routine endoscopy without artificial intelligence assistance

Routine endoscopy with artificial intelligence-assisted interpretation

Routine endoscopy assisted by artificial intelligence to enhance the detection of H. pylori infection and premalignant gastric conditions.

Other: Routine endoscopy with artificial intelligence-assisted interpretation

Interventions

Routine endoscopy with artificial intelligence-assisted interpretation OTHER

(1) Improved detection of H. pylori infection, leading to timely eradication therapy. (2) Earlier identification of premalignant gastric conditions, facilitating appropriate surveillance endoscopy.

Routine endoscopy with artificial intelligence-assisted interpretation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will invite patients who need to undergo upper gastrointestinal endoscopy.

You may qualify if:

• Age 20-80
• Scheduled endoscopy

You may not qualify if:

• \. History of gastric surgery

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Yi-Chia Lee

Taipei, 10015, Taiwan

RECRUITING

Study Officials

• Tsung-Hsien Chiang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chia Lee, MD, PhD

CONTACT

886-2-23123456; yichialee@ntu.edu.tw

Tsung-Hsien Chiang, MD,PhD

CONTACT

886-2-23123456; thchiang@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: December 24, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

TW (1)