Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Study

March 14, 2016 updated by: MOHAMED ABDELLATIF, Mansoura University

Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Multicenter Study

There are controversies about the best sites -biopsy based -tests for H pylori associated gastritis. The study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

. The study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia. 400 patients with dyspepsia are planned to be enrolled in this study. in addition to the routine antral biospy, corpus biospies are taken to evaluate the optimal site of gastric mucosal biopsy for identification of Helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

Study Type

Interventional

Enrollment (Anticipated)

400

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 Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients included in this study are those with peptic ulcer disease, previous upper gastrointestinal surgery, a known or a suspected past history of H.pylori eradication therapy, a personal or first-degree family history of gastric cancer

Exclusion Criteria:

  • those having received antibiotic or proton pump inhibitor treatment one month beforehand

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ENDOSCOPIC GASTRIC BIOPSIES
ENDOSCOPIC BIOPSEIS TAKEN FROM BOTH ANTRUM AND CORPUS FOR H PYLORI DETECTION
Other: ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY
ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
H PYLORI POSITIVITY
Time Frame: 2 YEARS
2 YEARS

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Chair: MOHAMED ABDELLATIF, ASS PROF, Mansoura faculty of Medicine

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

June 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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