Endoscopic Biopsy to Detect Helicobacter Pylori

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Diagnostic test: stomach biopsies

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients attending the outpatient Gastroenterology clinic and the Emergency Department of the "Dr. Jose Eleuterio González" University Hospital with a medical indication for performing upper gastrointestinal endoscopy for biopsy and detection of Helicobacter pylori infection.

Description

Inclusion Criteria:

• Older than 18 years
• Have a clinical file.
• Medical indication for upper gastrointestinal endoscopy and biopsy to detect Helicobacter pylori

Exclusion Criteria:

• Active gastrointestinal bleeding
• Antibiotic use in the last 30 days
• Hemodynamic instability
• Platelets <50,000 K/µL
• INR >1.5 or PT >50 sec
• Having received eradication treatment for Helicobacter pylori previously.
• History of gastric surgery
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 Antrum biopsy diagnostic performance	To determine the diagnostic performance in the detection of Helicobacter pylori in biopsies taken only from the gastric antrum for the determination of the positive predictive value, the negative predictive value, and sensitivity and specificity.	7 days

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Investigators: Study Director: Joel O. Jáquez, M.D., Hospital Universitario

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2020
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GA19-00004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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