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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05762991
- Acronym / sponsor ID
- 202111108RINC
- Conditions
- Helicobacter Pylori Infection, Premalignant Lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine endoscopy alone | – | –Routine endoscopy without artificial intelligence assistance |
| Routine endoscopy with artificial intelligence-assisted interpretation | – | Other: Routine endoscopy with artificial intelligence-assisted interpretationRoutine endoscopy assisted by artificial intelligence to enhance the detection of H. pylori infection and premalignant gastric conditions. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will invite patients who need to undergo upper gastrointestinal endoscopy.
Key inclusion criteria (2 listed)
- Age 20-80
- Scheduled endoscopy
Key exclusion criteria (1 listed)
- 1. History of gastric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine 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. | Other | Routine endoscopy with artificial intelligence-assisted interpretation |
Primary outcome
Gastric cancer-specific mortality
Time frame: Up to 5 years
The primary endpoint is gastric cancer-specific mortality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided. The study was based on the images and histological data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsung-Hsien Chiang, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Premalignant Lesion, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chia Lee, MD, PhD (886-2-23123456 ext. 265689, yichialee@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric cancer-specific mortality (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.