- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02945137
Optimal Site for Rapid Urease Test in the Stomach
April 16, 2018 updated by: Jun-Hyung Cho, Soonchunhyang University Hospital
Comparison of Rapid Urease Test Between the Gastric Body and Antrum in Helicobacter Pylori-Infected Stomach
The accurate diagnosis of H. pylori infection is an important step for establishing the strategy for gastric cancer prevention.
During endoscopy, rapid urease test (RUT) is the first of biopsy-based H. pylori tests.
Despite indirect test for H. pylori detection, RUT shows rapid result with good sensitivity and specificity.
Several study reported that H. pylori density was related to positive reaction time of RUT.
However, there was no study comparing the positive reaction times of RUT according to biopsy site, degree of gastric atrophy, and intestinal metaplasia.
Study Overview
Status
Completed
Conditions
Detailed Description
The aims of this study were to: (1) assess the positive reaction times of RUT in the body and antrum, (2) investigate the association between the difference of RUT results (body and antrum) and gastric atrophy, and intestinal metaplasia, and (3) evaluate the optimal biopsy site for RUT according to degree of gastric atrophy in Korean population.
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 04401
- Digestive Disease Center, Soonchunhyang University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The subjects who underwent an upper gastrointestinal endoscopy were enrolled in this study at a single, tertiary-care, academic medical center.
During endoscopy, rapid urease tests would be performed in the body and antrum.
Description
Inclusion Criteria:
- Subjects who underwent upper endoscopy and rapid urease test
Exclusion Criteria:
- : age < 20 or > 70 years; anemia (serum hemoglobin level < 10 g/dL); severe systemic disease or advanced chronic liver disease; use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics; a history of H. pylori eradication; a history of gastric surgery; a recent history of upper gastrointestinal bleeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive reaction time of urease test
Time Frame: within 24 hours
|
Color change to red or pink means positivity
|
within 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jun-Hyung Cho, M.D., Assistant professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
October 25, 2016
First Submitted That Met QC Criteria
October 25, 2016
First Posted (Estimate)
October 26, 2016
Study Record Updates
Last Update Posted (Actual)
April 18, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- SCHDDC 2016-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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