Rapid Urease Test for Helicobacter Pylori in Population Who Stop Proton Pump Inhibitor Less Than 2 Weeks Compared With Histology

Patients with dyspepsia will have negative impact to their life and common cause is Helicobactor pylori infection. Rapid urease test is the easy available and rapid method to test the infection but the test may be interfered by proton pump inhibitor, bismuth or antibiotics .In general, patients with dyspepsia usually take proton pump inhibitor to relieve dyspepsia so those patients may not stop the drug before test the infection with rapid urease test. So author aims to measure the sensitivity of rapid urease test from biopsy of body, which H. pylori would migrate if the patients still take proton pump inhibitor and biopsy of antrum, which is standard location of biopsy compare to pathology for H. pylori in each sites in patients who do not stop taking proton pump inhibitor

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Diagnostic test: rapid urease test

Detailed Description

The investigators contacted patients who had an appointment for esophagoendoscopy(EGD) at Chulalongkorn Hospital to inform and review patient's history. If patients matched inclusion and did not meet exclusion criteria, the participants would tell the information of the study including proposal, method, risk and benefit then the investigators asked for consent to participate in the study.

If patients decided to participate then the investigator corrected the information in CRF form which was sex, age, underlying disease, smoking history, alcohol drinking history, current and past medication especially PPI and NSIADs, EGD and rapid urease test history, H. pylori treatment history, duration of taking PPI drug.

EGD was done by endoscopist with standard method. The investigator performed biopsy at antrum, 5 cm proximal to pylorus lesser curvature, and body, greater curvature opposite to angularis by standard forceps. The biopsy would take 2 times from each site for rapid urease test and histopathology test for H. pylori. The endoscopists change forceps after finishing biopsy in each site to reduce contamination. The EGD finding was recorded After the investigators test H. pylori by rapid urease test, the result was read at 24 hours at room temperature. The color changing from yellow to pink was positive test, which mean there was H. pylori infection. In contrast, negative test was no color changing.

For Histopathologic test, the investigators fixed sample in formalin, infiltrated the tissue with paraffin then embedded. Stained with Hematoxylin & Eosin and looked for H. pylori by 2 histopathologists, who were blinded the result to each other and result of rapid urease test. If negative study, the histopathologists would stain tissue with giemsa and corrected data again. All gastric tissue will be sent for immunohistochemistry as a gold standard for this study.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • State/Region/Province/District
    • Bangkok, State/Region/Province/District, Thailand, 10330
      • King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with dyspepsia and have indication for esophagogastroscopy
• Patients who take PPI at least 2 weeks and stop the drug less than 2 weeks
• Age above 18 years old

Exclusion Criteria:

• Patients who diagnosed to have iron deficiency anemia and have signs of previously bleeding gastric ulcer
• Active upper gastrointestinal bleeding or recent bleeding
• previous gastric surgery
• patients who take bismuth or antibiotic in last 4 weeks
• Coagulopathy, INR>1.5, Platelet < 100,000
• gastric cancer
• Life expectancy less than 3 months
• Deny to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study; Rapid urease test is the test for H. pylori infection by detect the change of pH by urease enzyme metabolism.; Pathologic test for H. pylori by H&E stain and Giemsa stain; All tissues will be sent to immunohistochemistry as a gold standard	Diagnostic test: rapid urease test; Rapid urease test is the test for H. pylori infection by detect the change of pH by urease enzyme metabolism. Pathologic test for H. pylori by H&E stain and Giemsa stain Gold standard is a immunohistochemistry.; Other Names: pathologic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of rapid urease test for dectection of H.pylori from gastric antrum and body	The sensitivity of rapid urease test for H.pylori diagnosis at antrum, body and both in patients stopping proton pump inhibitors less than 2 weeks	24 hours after test by rapid urease test

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital
• Investigators: Principal Investigator: Pittayanon Pittayanon, MD, King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: RP015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No