Narrow-band ImagingNCT05345314
Endoscopic Grading of Intestinal Metaplasia
An observational study of Narrow-band Imaging and Magnifying Endoscopy, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
Long-term Helicobacter pylori infection causes premalignant gastric conditions, such as atrophic gastritis and intestinal metaplasia. Image-enhanced endoscopy techniques such as narrow-band imaging (NBI) and magnifying endoscopy improve the diagnosis of gastric intestinal metaplasia (GIM). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Narrow-band Imaging, Magnifying Endoscopy, Gastric Intestinal Metaplasia
- What is being tested?
- Narrow-band imaging endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 242 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2022to 24 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a single academic hospital.
Who may be able to join
- Gastroscopy can be performed
- Pathological analysis can be performed for analysis of gastric atrophy and intestinal metaplasia
Who cannot join
- Age < 20 or > 80 years
- Anemia (serum hemoglobin level < 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics
- History of H. pylori eradication
- History of gastric surgery
- Recent history of upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, 140-887
About this study
Official title: Endoscopic Grading of Gastric Intestinal Metaplasia: a Validation Study in Korea
Long-term Helicobacter pylori infection causes premalignant gastric conditions, such as atrophic gastritis and intestinal metaplasia. Image-enhanced endoscopy techniques such as narrow-band imaging (NBI) and magnifying endoscopy improve the diagnosis of gastric intestinal metaplasia (GIM). However, there are no comparative data on the utility of NBI and magnifying endoscopy for diagnosing GIM.
Read the detailed description
This study aims to evaluate the diagnostic performance of NBI and magnifying endoscopy for GIM in a country with high risk of gastric premalignant lesions.
- Being tested
- Narrow-band imaging endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow-band imaging endoscopyProcedure or surgery
During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric intestinal metaplasia
Gastric intestinal metaplasia would be assessed using pathological examination.
Measured: 4 weeks
Secondary outcomes (1)
Degree of chronic gastritis
Gastric atrophy would be evaluated on the basis of histopathological examination (updated Sydney system).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Mar 2022
- Primary completion28 Feb 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narrow-band ImagingStudies of the same condition, open and under way.
- 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Hyung Cho, Soonchunhyang University Hospital
- Investigators
- Jun-Hyung Cho, M.D., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345314
- Sponsor's protocol ID
- SCH-EGD-2022
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Grading of Gastric Intestinal Metaplasia: a Validation Study in Korea
- ClinicalTrials.gov ID
- NCT05345314
- Acronym / sponsor ID
- SCH-EGD-2022
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 25 Apr 2022 (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.
Long-term Helicobacter pylori infection causes premalignant gastric conditions, such as atrophic gastritis and intestinal metaplasia. Image-enhanced endoscopy techniques such as narrow-band imaging (NBI) and magnifying endoscopy improve the diagnosis of gastric intestinal metaplasia (GIM). However, there are no comparative data on the utility of NBI and magnifying endoscopy for diagnosing GIM.
Detailed description
This study aims to evaluate the diagnostic performance of NBI and magnifying endoscopy for GIM in a country with high risk of gastric premalignant lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a single academic hospital.
Key inclusion criteria (2 listed)
- Gastroscopy can be performed
- Pathological analysis can be performed for analysis of gastric atrophy and intestinal metaplasia
Key exclusion criteria (8 listed)
- Age < 20 or > 80 years
- Anemia (serum hemoglobin level < 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics
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 |
|---|---|---|
| Narrow-band imaging endoscopyDuring endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging. | Procedure or surgery | – |
Primary outcome
Gastric intestinal metaplasia
Time frame: 4 weeks
Gastric intestinal metaplasia would be assessed using pathological examination.
1 secondary outcome
Degree of chronic gastritis
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jun-Hyung Cho, M.D. principal investigator
Soonchunhyang 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 Narrow-band Imaging and Magnifying Endoscopy, run by Soonchunhyang University Hospital at 1 site in South Korea.
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 8 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: finished, as of the sponsor's last update on 25 Apr 2023. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric intestinal metaplasia (time frame: 4 weeks). 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 25 Apr 2023.