Optimal Site for Rapid Urease Test in the Stomach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02945137
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Jun-Hyung Cho, Soonchunhyang University Hospital

Brief Summary:
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.

Condition or disease
Helicobacter Pylori Infection

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
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Comparison of Rapid Urease Test Between the Gastric Body and Antrum in Helicobacter Pylori-Infected Stomach
Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Primary Outcome Measures :
  1. Positive reaction time of urease test [ Time Frame: within 24 hours ]
    Color change to red or pink means positivity

Biospecimen Retention:   Samples Without DNA
Biospecimen would be obtained for urease test (commercial name: CLOtest).

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02945137

Korea, Republic of
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, Korea, Republic of, 04401
Sponsors and Collaborators
Soonchunhyang University Hospital
Principal Investigator: Jun-Hyung Cho, M.D. Assistant Professor

Responsible Party: Jun-Hyung Cho, Assistant Professor, Soonchunhyang University Hospital Identifier: NCT02945137     History of Changes
Other Study ID Numbers: SCHDDC 2016-10
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections