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

Kyung Hee University

Status

Unknown

Conditions

Helicobacter Pylori Infection

Treatments

Device: Dual focus with narrow band imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT03973242

DFHP2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

292 estimated patients

Sex

All

Ages

19 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

292 participants in 2 patient groups, including a placebo group

DF-NBI

Active Comparator group

Description:

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.

Treatment:

Device: Dual focus with narrow band imaging

Placebo Comparator group

Description:

Conventional white light endoscopy use It is routine practice for the upper gastrointestinal endoscopy.

Treatment:

Device: Dual focus with narrow band imaging