Yi-Chia Lee
Taipei, 10015, Taiwan
Location status: Recruiting
NCT Number: NCT05762991
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.
Interested in participating?
Request Info20 year–80 year
All sexes
Observational
Taipei, 10015, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(1) Improved detection of H. pylori infection, leading to timely eradication therapy. (2) Earlier identification of premalignant gastric conditions, facilitating appropriate surveillance endoscopy.
Time frame: Up to 5 years
The primary endpoint is gastric cancer-specific mortality.
Contact information is provided by the study sponsor or research team.
Tsung-Hsien Chiang, MD,PhD
CONTACT
886-2-23123456 ext. 265427
Yi-Chia Lee, MD, PhD
CONTACT
886-2-23123456 ext. 265689
National Taiwan University Hospital
Other
Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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