Endoscopic Grading of Intestinal Metaplasia

• Sponsor: Soonchunhyang University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05345314
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 18.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Narrow-band Imaging; Magnifying Endoscopy; Gastric Intestinal Metaplasia	Procedure: Narrow-band imaging endoscopy

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

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Endoscopic Grading of Gastric Intestinal Metaplasia: a Validation Study in Korea
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Gastric intestinal metaplasia [4 weeks]

   Gastric intestinal metaplasia would be assessed using pathological examination.

Secondary Outcome Measures

1. Degree of chronic gastritis [4 weeks]

   Gastric atrophy would be evaluated on the basis of histopathological examination (updated Sydney system).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Digestive Disease Center, Soonchunhyang University Hospital	Seoul		Korea, Republic of	140-887

Sponsors and Collaborators

• Soonchunhyang University Hospital

Investigators

• Principal Investigator: Jun-Hyung Cho, M.D., Soonchunhyang University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun-Hyung Cho, Associate Professor, Soonchunhyang University Hospital
• ClinicalTrials.gov Identifier: NCT05345314
• Other Study ID Numbers: SCH-EGD-2022
• First Posted: Apr 25, 2022
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metaplasia

Study Results

No Results Posted as of Jun 30, 2022