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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric cancer-specific mortality | The primary endpoint is gastric cancer-specific mortality. | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
1. History of gastric surgery
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This study will invite patients who need to undergo upper gastrointestinal endoscopy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Chia Lee, MD, PhD | Contact | 886-2-23123456 | 265689 | yichialee@ntu.edu.tw |
| Tsung-Hsien Chiang, MD,PhD | Contact | 886-2-23123456 | 265427 | thchiang@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Tsung-Hsien Chiang, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yi-Chia Lee | Recruiting | Taipei | 10015 | Taiwan |
The study was based on the images and histological data.
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