Dual-focus Magnification With Narrow-band Imaging in Helicobacter Pylori Infection

NCT ID: NCT03973242

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2020-03-31

Brief Summary

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Dual-focus with narrow-band imaging (DF-NBI) is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with conventional white light (WL) endoscopy to predict Helicobacter pylori infection.

Detailed Description

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The subjects are patients who underwent upper gastrointestinal endoscopy under sedation. Participants are randomized into DF-NBI and WL groups. Rapid urease test will be performed in all cases. By captured images of gastric mucosa, classification of DF-NBI for Helicobacter pylori infected mucosa will be developed and validated. The established classification of WL for Helicobacter pylori infection will be used. Finally, the investigators will compare the accuracy between two groups based on each classification.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study group: Dual Focus with Narrow band imaging Control group: White light endoscopy
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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DF-NBI

Initially, gastric mucosa is observed by conventional wight light endoscopy. Then, converting to dual-focus mode with narrow band imaging is done. Gastric mucosa is observed once again by DF-NBI mode.

Group Type ACTIVE_COMPARATOR

Dual focus with narrow band imaging

Intervention Type DEVICE

dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity

WL

Conventional white light endoscopy use It is routine practice for the upper gastrointestinal endoscopy.

Group Type PLACEBO_COMPARATOR

Dual focus with narrow band imaging

Intervention Type DEVICE

dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity

Interventions

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Dual focus with narrow band imaging

dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* consecutive patients who have undergone uper gastrointestinal endoscopy for diagnosis or screening of cancer.

Exclusion Criteria

* Those whose Hp status had already been clarified
* Pregnancy
* History of partial gastrectomy
* Taking proton pump inhibitor, antithrombotics or antibiotics within 4 weeks
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jung-Wook Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kyung Hee University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-Wook Kim, MD, PhD

Role: CONTACT

82-2-958-8141

Yoomin Park, MD

Role: CONTACT

82-2-958-8200

Facility Contacts

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Jae-Young Jang, MD, PhD

Role: primary

82-2-958-8149

Other Identifiers

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DFHP2018

Identifier Type: -

Identifier Source: org_study_id

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