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

Primary Purpose

Helicobacter Pylori Infection

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dual focus with narrow band imaging
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Helicobacter Pylori Infection

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kyung Hee University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DF-NBI

WL

Arm 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.

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

Outcomes

Primary Outcome Measures

Accurate prediction of Helicobacter pylori status
Sensitivity, specificity, PPV, and NPV

Secondary Outcome Measures

Full Information

First Posted
May 31, 2019
Last Updated
May 31, 2019
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03973242
Brief Title
Dual-focus Magnification With Narrow-band Imaging in Helicobacter Pylori Infection
Official Title
Usefulness of Dual-focus Magnification With Narrow-band Imaging in the Prediction of Helicobacter Pylori Infection: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study group: Dual Focus with Narrow band imaging Control group: White light endoscopy
Masking
Participant
Allocation
Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DF-NBI
Arm Type
Active Comparator
Arm 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.
Arm Title
WL
Arm Type
Placebo Comparator
Arm Description
Conventional white light endoscopy use It is routine practice for the upper gastrointestinal endoscopy.
Intervention Type
Device
Intervention Name(s)
Dual focus with narrow band imaging
Intervention Description
dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity
Primary Outcome Measure Information:
Title
Accurate prediction of Helicobacter pylori status
Description
Sensitivity, specificity, PPV, and NPV
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Wook Kim, MD, PhD
Phone
82-2-958-8141
Email
iloveact@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Yoomin Park, MD
Phone
82-2-958-8200
Email
uminee@naver.com
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Young Jang, MD, PhD
Phone
82-2-958-8149
First Name & Middle Initial & Last Name & Degree
Jung-Wook Kim, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If needed, IPD will be shared.

Learn more about this trial

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

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