Endoscopic Grading of Intestinal Metaplasia

April 23, 2023 updated by: Jun-Hyung Cho, Soonchunhyang University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 140-887
        • Digestive Disease Center, Soonchunhyang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a single academic hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric intestinal metaplasia
Time Frame: 4 weeks
Gastric intestinal metaplasia would be assessed using pathological examination.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of chronic gastritis
Time Frame: 4 weeks
Gastric atrophy would be evaluated on the basis of histopathological examination (updated Sydney system).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

April 24, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH-EGD-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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