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

Usefulness of Dual-focus Magnification With Narrow-band Imaging in the Prediction of Helicobacter Pylori Infection: a Prospective Randomized Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03973242

Enrollment

292

Registered

2019-06-04

Start date

2018-03-15

Completion date

2020-03-31

Last updated

2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Brief summary

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

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.

Interventions

DEVICEDual focus with narrow band imaging

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Accurate prediction of Helicobacter pylori status	1 day	Sensitivity, specificity, PPV, and NPV

Countries

South Korea

Contacts

Primary ContactJung-Wook Kim, MD, PhD

iloveact@hanmail.net82-2-958-8141

Backup ContactYoomin Park, MD

uminee@naver.com82-2-958-8200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026