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

Not Applicable

• Conditions: Helicobacter Pylori Infection
• Interventions: Device: Dual focus with narrow band imaging

• Registration Number: NCT03973242
• Lead Sponsor: Kyunghee University Medical Center

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.

Study Timeline

• Study Start: 2018-03-15
• Status Verified: 2019-05
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Last Update Submitted: 2019-05-31
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DF-NBI	Dual focus with narrow band imaging	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.
WL	Dual focus with narrow band imaging	Conventional white light endoscopy use It is routine practice for the upper gastrointestinal endoscopy.

Primary Outcome Measures

Name	Time	Method
Accurate prediction of Helicobacter pylori status	1 day	Sensitivity, specificity, PPV, and NPV

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of