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NCT03973242 Clinical Trial

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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03973242
Other study ID # DFHP2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2018
Est. completion date March 31, 2020

Study information
Verified date May 2019
Source Kyunghee University Medical Center
Contact Jung-Wook Kim, MD, PhD
Phone 82-2-958-8141
Email iloveact@hanmail.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 292
Est. completion date March 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Dual focus with narrow band imaging
dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity

Locations
Country Name City State
Korea, Republic of Kyung Hee University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accurate prediction of Helicobacter pylori status Sensitivity, specificity, PPV, and NPV 1 day
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