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

• Sponsor: Mansoura University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02675010
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 16.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori; Gastric Antrum; CORPUS BIOPSIES	Other: ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Multicenter Study
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. H PYLORI POSITIVITY [2 YEARS]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospital	Mansoura		Egypt

Sponsors and Collaborators

• Mansoura University

Investigators

• Study Chair: MOHAMED ABDELLATIF, ASS PROF, MANSOURA FACULTY OF MEDICINE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MOHAMED ABDELLATIF, ass. prof., Mansoura University
• ClinicalTrials.gov Identifier: NCT02675010
• Other Study ID Numbers: H1
• First Posted: Feb 5, 2016
• Last Update Posted: Mar 16, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Gastritis; Gastritis, Atrophic

Study Results

No Results Posted as of Mar 16, 2016