Helicobacter Pylori Infection Clinical Trial
Official title:
Comparison of Two Methods for Endoscopic Biopsy to Detect Helicobacter Pylori
Helicobacter pylori (H. pylori) infection represents one of the most common chronic
infections that affect humans.Endoscopy must be performed to take biopsies for detection of
Helicobacter pylori in patients with alarm symptoms. The Sydney Protocol is the recommended
strategy that guarantees maximum diagnostic yield. This is a prospective uncontrolled
cross-sectional clinical trial.
Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients
with epigastric pain, weight loss, iron-deficiency anemia, individuals with dyspepsia over 60
years of age or younger with alarm symptoms (weight loss, dysphagia, vomiting,
gastrointestinal bleeding, among others).
The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield.
Histology is expensive since it requires time for biopsy processing and trained personnel for
staining and interpretation but it provides additional information on the degree of
inflammation and complications such as atrophic gastritis, intestinal metaplasia, and
malignancy. The modified Sydney protocol includes two biopsies from the antrum, two from the
body, and one form the incisura.
The hypothesis is that the histopathological study of two biopsies obtained from the gastric
antrum for the determination of Helicobacter pylori infection has a similar diagnostic yield
compared to the gold standard (Sydney protocol). This is a prospective uncontrolled
cross-sectional clinical trial.
Patients older than 18 years with a medical indication for performing upper gastrointestinal
endoscopy for biopsy and detection of Helicobacter pylori infection in the period from
january to May 2020.
A sample size of 67 patients was calculated using the diagnostic test comparison formula, in
order to compare the sensitivity and specificity in patients with indications for a biopsy
taken with the Sydney protocol from those taken only from the gastric antrum.
Expecting a sensitivity of 89% in the Sydney protocol With a Zα of 1.96 and a maximum
amplitude of 7.5% (CI = 15), at least 67 study subjects are required with the two diagnostic
tests.
Cold biopsies will be taken using an oval head clamp with a stiletto, 2.3 mm in diameter and
180 cm in length of the gastric mucosa with the current standardized method (Sydney
protocol).
The samples will be sent to the pathology service in two bottles with formalin; in one, the
two biopsies obtained from the antrum will be labeled as "bottle 1" and in the second bottle
obtained from the body and the incisura will be labeled as "bottle 2"; this will be blinded
for the pathologist who analyzes the slides.
Samples will be processed in a conventional manner, stained for interpretation with
hematoxylin-eosin and Giemsa.
Upon obtaining the pathology report, the data will be analyzed in the SPSS statistical
program by 2X2 contingency tables for the determination of the positive predictive value, the
negative predictive value, and the sensitivity and specificity of the biopsies taken from the
antrum compared to healthy population and those who possess the infection using the gold
standard.
In addition, the diagnostic yield of the biopsies taken from the antrum of patients who use
PPI or have atrophic gastritis will be analyzed separately.
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