Endoscopic Grading of Intestinal Metaplasia

Gastric Intestinal Metaplasia Clinical Trial

Official title:

Endoscopic Grading of Gastric Intestinal Metaplasia: a Validation Study in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345314
• Other study ID #: SCH-EGD-2022
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Gastric Intestinal Metaplasia
• Magnifying Endoscopy
• Metaplasia

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