NCT05345314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

April 19, 2022

Last Update Submit

April 23, 2023

Conditions

Narrow-band ImagingMagnifying EndoscopyGastric Intestinal Metaplasia

Outcome Measures

Primary Outcomes (1)

  • Gastric intestinal metaplasia

    Gastric intestinal metaplasia would be assessed using pathological examination.

    4 weeks

Secondary Outcomes (1)

  • Degree of chronic gastritis

    4 weeks

Interventions

Narrow-band imaging endoscopyPROCEDURE

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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Gastroscopy can be performed
  • Pathological analysis can be performed for analysis of gastric atrophy and intestinal metaplasia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 140-887, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen would be obtained for pathological analysis.

Study Officials

  • Jun-Hyung Cho, M.D.

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

March 1, 2022

Primary Completion

February 28, 2023

Study Completion

April 24, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)