Clinical Utility of Upper Endoscopy in Diagnosis of Helicobacter Pylori Infection

March 27, 2023 updated by: Walaa Mohamed Omar, Sohag University

Helicobacter pylori (H. pylori) is a gram-negative flagellated bacterium that inhabits the gastric environment of 60.3% of the world population, and its prevalence is particularly high in countries with inferior socioeconomic conditions, exceeding 80% in some regions of the globe , This phenomenon occurs among other reasons, due to the unsatisfactory basic sanitation and high people aggregations observed in many under developed nations, scenarios that favour the oral-oral and fecal-oral transmissions of H.pylori.Another possible transmission route of this pathogen is the sexual route.

Several studies have shown that the colonization of H.pylori could be negatively and positively associated with the induction and progression of several diseases .It has been reported to be linked to gastric and duodenal ulcer, gastric carcinoma, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma and gastritis ,A positive association also reported between H.pylori infection and oesophageal cancer.

Moreover, evidence is also available on the positive association between H.pylori and non gastrointestinal diseases such as diabetes mellitus , coronary artery disease

, and anaemia. Abdominal pain and discomfort, nausea, burping, and loss of appetite are common symptoms of H.pylori infection. Other symptoms include, bloating, weight loss, and heart burn.

Several approaches are used in the detection of H. pylori. Both the invasive and the non-invasive methods are employed in the detection of H. pylori in a patient. Many factors, however, influence choices in the method of diagnosis: availability of diagnostic instruments/materials, sampling population, and competency and experience of the physicians/clinicians .

Invasive methods include endoscopic evaluation, histology, rapid urease test (RUT), and bacterial culture. Non-invasive methods include urea breath test (UBT), stool antigen test (SAT), serology, and molecular diagnostic approaches .Endoscopy is an accurate test for diagnosing the infection as well as the inflammation.

Endoscopy also allows the determination of the severity of gastritis with biopsies as well as the presence of ulcers, MALT lymphoma and cancer.

Real-time endoscopy along with conventional white light imaging (WLI)and image enhanced endoscopic (IEE)techniques, such as narrow-band imaging (NBI), linked color imaging (LCI) and blue laser imaging (BLI), appear to have important roles in clinical practice to identify H. pyloriinfected status .

Another endoscopic technique is i-scan digital chromoendoscopy, which is a digital contrast method that enhances minute mucosal structures and subtle changes in color . The overall diagnostic accuracy of i-scan is 97% compared to 78% for WLI .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

345

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Safaa Kh Abdallah, associate professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (≥18 years old) of both genders.
  • Symptoms should be present within three months and have started ≥ six months before diagnosis of dyspepsia according to RomeIII criteria.

Exclusion Criteria:

  • Previous H.pylori eradication therapy.
  • History of gastric surgery.
  • Patients declining to provide informed consent.
  • Pregnant and lactating women.
  • Severe coagulopathy.
  • liver cirrhosis, portal hypertensive gastropathy.
  • Other causes of chronic gastritis (bile reflux gastritis, Crohn's disease, autoimmune gastritis, chemical gastritis, eosinophilic gastritis).
  • Patients without endoscopic features or signs of gastritis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of cases with H.pylori infection among all patients subjected to upper endoscopy.
Time Frame: 18 months
Evaluate the diagnostic accuracy of I-scan technique in doagnosis of H.pylori infection
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-03-17MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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