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OpenTrials
Completed

NCT Number: NCT02945137

Optimal Site for Rapid Urease Test in the 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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Positive reaction time of urease test

    Time frame: within 24 hours

    Color change to red or pink means positivity

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

Comparison of Rapid Urease Test Between the Gastric Body and Antrum in Helicobacter Pylori-Infected Stomach

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 26, 2016
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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