Helicobacter Pylori InfectionNCT05762991
Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion
An observational study of Helicobacter Pylori Infection and Premalignant Lesion, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection, Premalignant Lesion
- What is being tested?
- Routine endoscopy with artificial intelligence-assisted interpretation
- How many people
- 6,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Dec 2021to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will invite patients who need to undergo upper gastrointestinal endoscopy.
Who may be able to join
- Age 20-80
- Scheduled endoscopy
Who cannot join
- 1. History of gastric surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Yi-Chia Lee
Taipei, 10015
Yi-Chia Lee, yichialee@ntu.edu.tw
About this study
Official title: Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection, Premalignant Lesion
- Being tested
- Routine endoscopy with artificial intelligence-assisted interpretation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine endoscopy with artificial intelligence-assisted interpretationOther
(1) Improved detection of H. pylori infection, leading to timely eradication therapy. (2) Earlier identification of premalignant gastric conditions, facilitating appropriate surveillance endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine endoscopy with artificial intelligence-assisted interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric cancer-specific mortality
The primary endpoint is gastric cancer-specific mortality.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start24 Dec 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsung-Hsien Chiang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762991
- Sponsor's protocol ID
- 202111108RINC
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study was based on the images and histological data.