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

Not Applicable
Conditions
Helicobacter Pylori Infection
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.

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.
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Accurate prediction of Helicobacter pylori status1 day

Sensitivity, specificity, PPV, and NPV

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kyung Hee University Hospital

🇰🇷

Seoul, Korea, Republic of

Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Jae-Young Jang, MD, PhD
Contact
82-2-958-8149
Jung-Wook Kim, M.D., Ph.D.
Principal Investigator

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