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Endoscopic Biopsy to Detect Helicobacter Pylori

NCT04237220 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2020-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DIAGNOSTIC_TEST

stomach biopsies

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.

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Joel O. Jáquez, M.D. · Hospital Universitario

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-25
Primary Completion
2020-05-15
Completion
2020-05-20

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04237220 on ClinicalTrials.gov