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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05345314
Other study ID # SCH-EGD-2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date April 24, 2023

Study information

Verified date April 2023
Source Soonchunhyang University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). However, there are no comparative data on the utility of NBI and magnifying endoscopy for diagnosing GIM.


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.


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date April 24, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Gastroscopy can be performed - Pathological analysis can be performed for analysis of gastric atrophy and intestinal metaplasia Exclusion Criteria: - 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

Study Design


Intervention

Procedure:
Narrow-band imaging endoscopy
During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.

Locations

Country Name City State
Korea, Republic of Digestive Disease Center, Soonchunhyang University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastric intestinal metaplasia Gastric intestinal metaplasia would be assessed using pathological examination. 4 weeks
Secondary Degree of chronic gastritis Gastric atrophy would be evaluated on the basis of histopathological examination (updated Sydney system). 4 weeks
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