Endoscopic Grading of Intestinal Metaplasia

Completed

• Conditions: Magnifying Endoscopy; Narrow-band Imaging; Gastric Intestinal Metaplasia

• Registration Number: NCT05345314
• Lead Sponsor: Soonchunhyang University Hospital

Brief 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.

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 Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Primary Completion: 2023-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Study Completion: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric intestinal metaplasia	4 weeks	Gastric intestinal metaplasia would be assessed using pathological examination.

Secondary Outcome Measures

Name	Time	Method
Degree of chronic gastritis	4 weeks	Gastric atrophy would be evaluated on the basis of histopathological examination (updated Sydney system).

Trial Locations

Locations (1)

Digestive Disease Center, Soonchunhyang University Hospital; 🇰🇷 Seoul, Korea, Republic of