Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04233684 |
| Other study ID # |
RP015 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
February 1, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
King Chulalongkorn Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
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.
