Magnifying NBI Endoscopy for Gastric Condition | NCT04489030

Studies
Magnifying NBI Endoscopy for Gastric Condition

NCT04489030

Sponsor

Soonchunhyang University Hospital

Status

Completed

Last Update Posted

Sep 29, 2020Actual

Enrollment

254Actual

Phase

Not provided

Conditions

Gastritis H Pylori

Interventions

Magnifying 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

Sep 2020

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

Jun 1, 2016Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Jul 24, 2020

First Submission Date that Met QC Criteria

Jul 24, 2020

First Posted Date

Jul 28, 2020Actual

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

Sep 28, 2020

Last Update Posted Date

Sep 29, 2020Actual

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)

Yes

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

Recently, the improved resolution with standard endoscopy allows the close observation of highly inflamed gastric mucosa without a magnifying view. In a previous study, the investigators established the endoscopic classification of H. pylori-infected stomach by non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was 91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous gastric lesions between standard and magnifying endoscopy.

Detailed Description

The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard endoscopy for predicting H. pylori-infection status and precancerous gastric conditions, compared to magnifying NBI endoscopy

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

254Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
H. pylori infection status	H. pylori positivity would be assessed using rapid urease test.	1 month
Degree of chronic gastritis	Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gastroscopy can be performed
H. pylori test and pathological analysis can be performed

Exclusion Criteria:

Age < 20 or > 70 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

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 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.	Digestive Disease Center, Soonchunhyang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soonchunhyang University Hospital		Seoul			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