Back to resultsValue of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Study
Primary Purpose
Helicobacter Pylori, Gastric Antrum, CORPUS BIOPSIES
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY
Sponsored by
About this trial
This is an interventional diagnostic trial for Helicobacter Pylori
Eligibility Criteria
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
Sites / Locations
- Mansoura University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ENDOSCOPIC GASTRIC BIOPSIES
Arm Description
ENDOSCOPIC BIOPSEIS TAKEN FROM BOTH ANTRUM AND CORPUS FOR H PYLORI DETECTION
Outcomes
Primary Outcome Measures
H PYLORI POSITIVITY
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02675010
Brief Title
Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Study
Official Title
Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori, Gastric Antrum, CORPUS BIOPSIES
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ENDOSCOPIC GASTRIC BIOPSIES
Arm Type
Other
Arm Description
ENDOSCOPIC BIOPSEIS TAKEN FROM BOTH ANTRUM AND CORPUS FOR H PYLORI DETECTION
Intervention Type
Other
Intervention Name(s)
ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY
Intervention Description
ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY
Primary Outcome Measure Information:
Title
H PYLORI POSITIVITY
Time Frame
2 YEARS
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MOHAMED ABDELLATIF, ASS PROF
Organizational Affiliation
MANSOURA FACULTY OF MEDICINE
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospital
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Study
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