Endoscopic Grading of Intestinal Metaplasia | NCT05345314

Studies
Endoscopic Grading of Intestinal Metaplasia

NCT05345314

Sponsor

Soonchunhyang University Hospital

Status

Completed

Last Update Posted

Apr 25, 2023Actual

Enrollment

242Actual

Phase

Not provided

Conditions

Narrow-band Imaging
Magnifying Endoscopy
Gastric Intestinal Metaplasia

Interventions

Narrow-band imaging endoscopy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

Apr 24, 2023Actual

First Submitted Date

Apr 19, 2022

First Submission Date that Met QC Criteria

Apr 19, 2022

First Posted Date

Apr 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2023

Last Update Posted Date

Apr 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun-Hyung Cho, Associate Professor, Soonchunhyang University HospitalPrincipal Investigator

Lead Sponsor

Soonchunhyang University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

242Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Narrow-band imaging endoscopy	Procedure	During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun-Hyung Cho, M.D.	Soonchunhyang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Disease Center, Soonchunhyang University Hospital		Seoul		140-887	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided