Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

April 19, 2012 updated by: Jun-Hyung Cho, Kyunghee University Medical Center

Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus

Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.

Study Overview

Status

Completed

Conditions

Detailed Description

Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.

Study Type

Observational

Enrollment (Actual)

585

Contacts and Locations

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

Study Locations

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent upper endoscopy in the Kyung Hee University Hospital

Description

Inclusion Criteria:

  • Patients who underwent upper endoscopy

Exclusion Criteria:

  • Age < 20 or > 70
  • Severe systemic disease or advanced chronic liver disease
  • Medication history of NSAID, PPI, H2 blockers or antibiotics
  • History of H. pylori eradication therapy
  • History of gastric surgery
  • Recent history of upper GI bleeding
  • Gastric or duodenal ulcer (including old scar change) during endoscopy
  • Anemia (Hemoglobin level < 10mg/dL)
  • Pangastritis

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

Cohorts and Interventions

Group / Cohort
H. pylori gastritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis accuracy for predicting of Helicobacter pylori infection status
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the clinicopathologic factors related to correct diagnosis
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Jun-Hyung Cho, M.D., Kyung Hee University Hospital

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

August 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (Estimate)

September 15, 2011

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHU-HP-2011

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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