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

Study Overview
=================
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.

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

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Device: Dual focus with narrow band imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study group: Dual Focus with Narrow band imaging Control group: White light endoscopy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DF-NBI<br>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. | Device: Dual focus with narrow band imaging<br>* dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity<br>|
| Placebo Comparator: WL<br>Conventional white light endoscopy use It is routine practice for the upper gastrointestinal endoscopy. | Device: Dual focus with narrow band imaging<br>* dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accurate prediction of Helicobacter pylori status | Sensitivity, specificity, PPV, and NPV | 1 day |