Helicobacter Pylori Infection, Premalignant Lesion
Conditions
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
(1) Improved detection of H. pylori infection, leading to timely eradication therapy. (2) Earlier identification of premalignant gastric conditions, facilitating appropriate surveillance endoscopy.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age 20-80 2. Scheduled endoscopy
Exclusion criteria
1\. History of gastric surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric cancer-specific mortality | Up to 5 years | The primary endpoint is gastric cancer-specific mortality. |
Countries
Taiwan
Contacts
National Taiwan University Hospital