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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stomach biopsies

Diagnostic Test

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.

Primary outcomes

2 Antrum biopsy diagnostic performance

Time frame: 7 days

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 and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

Comparison of Two Methods for Endoscopic Biopsy to Detect Helicobacter Pylori

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jan 23, 2020
Registry last updated: May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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