Skip to content

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 Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05762991
Enrollment
6000
Registered
2023-03-10
Start date
2021-12-24
Completion date
2028-12-31
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection, Premalignant Lesion

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.

Detailed description

This is a randomized clinical trial designed to evaluate the effectiveness of AI-assisted endoscopy compared with routine endoscopy in reducing gastric cancer-specific mortality. Participants will be allocated in a 1:1 ratio using a computer-generated randomization sequence after eligibility assessment and informed consent. One group will receive artificial intelligence-assisted interpretation for physician reference, while the control group will undergo routine endoscopy without AI assistance. In routine clinical practice, patients diagnosed with H. pylori infection receive antibiotic eradication therapy to reduce the risk of gastric cancer incidence and mortality, while those with premalignant gastric conditions are generally advised to undergo surveillance upper endoscopy every two years. We hypothesize that AI-assisted interpretation may further reduce gastric cancer-specific mortality through two mechanisms: (1) improved detection of H. pylori infection, enabling timely eradication therapy; and (2) earlier identification of gastric cancer via AI-supported detection of premalignant gastric conditions and appropriate recommendations for surveillance endoscopy. The primary endpoint is gastric cancer-specific mortality.

Interventions

OTHERRoutine endoscopy with artificial intelligence-assisted interpretation

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age 20-80 2. Scheduled endoscopy

Exclusion criteria

1\. History of gastric surgery

Design outcomes

Primary

MeasureTime frameDescription
Gastric cancer-specific mortalityUp to 5 yearsThe primary endpoint is gastric cancer-specific mortality.

Countries

Taiwan

Contacts

CONTACTYi-Chia Lee, MD, PhD
yichialee@ntu.edu.tw886-2-23123456
CONTACTTsung-Hsien Chiang, MD,PhD
thchiang@ntu.edu.tw886-2-23123456
PRINCIPAL_INVESTIGATORTsung-Hsien Chiang, MD, PhD

National Taiwan University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026