Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis

Treatment of H.pylori may not be achieved in many patients with chronic gastritis. Termination of the inflammatory respose produced by h.pylori may be useful in management of difficult cases. Heparanase is a pro-inflammatory mediator. Blocking of heparanase may relief the symptoms of chronic gastritis.

Study Overview

• Status: Completed
• Conditions: Chronic Gastritis
• Intervention / Treatment: Genetic: immunohistochemical detection of Heparanase in chronic gastritis

Detailed Description

Chronic gastritis (CG) is a very common disease. The incidence of CG is not accurately known. However, it is clear that the incidence of CG is increasing by advancing age. CG is divided into two main types; type A or immune and type B or non-immune gastritis. Both types of CG share the same histological features. However, type A is less common, usually affects the gastric fundus in a diffuse manner and separates the antrum. on the contrary; type B or non-immune CG, which is by far more common, inevitably develops in the antrum and progresses proximally. H. pylori-induced CG usually requires antibiotic therapy to eradicate the causative organism and subsequently terminate the inflammatory response and the symptoms of gastritis. However, eradication of H. pylori is difficult to be achieved in many patients. Previous studies established that there is a vicious circle between H. pylori-infected gastric epithelial cells and the gastric mucosal inflammatory cells. Heparanase (HPSE) is a mammalian ᵦ-endoglucoronidase. HPSE plays a critical role in multiple inflammatory processes by degrading and remodeling heparan sulfate polysaccharide chains in the extracellular matrix (ECM). This leads to release of multiple cytokines and chemokines which are located in the ECM. HPSE is a drug target, three inhibitors of this enzyme have been tested in early stage clinical trials. Many studies reported that the expression of HPSE is up-regulated in a variety of inflammatory conditions as ulcerative colitis, acute pancreatitis, acute vasculitis and sepsis. The aim of this work is to evaluate the role of heparanase (HPSE) in chronic gastritis (CG) by correlating the expression of HPSE to different histological features of CG as presence of H. pylori, chronic inflammatory infiltrate, gastric atrophy, intestinal metaplasia and neutrophil infiltrate (activity), to detect new treatment modalities in CG.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Maisa Hashem Mohammed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with symptomatic chronic gastritis who underwent upper endoscopy.

Exclusion Criteria:

• patients with gastric carcinoma.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients with chronic gastritis; patients with symptomatic chronic gastritis will undergo upper endoscopy, gastric biopsies will be obtained to establish giagnosis of chronic gastritis, detection of h.pylori and assessment of heparanase expression.	Genetic: immunohistochemical detection of Heparanase in chronic gastritis; immunohistochemical detection of Heparanase in chronic gastritis specimens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Heparanase expression in chronic gastritis.	we will correlate the intensity and percentage of immunohistochemical expression of Heparanase to different parameters of chronic gastritis as severity of gastric atrophy, chronic inflammation, intensity of neutrophilic infiltrate and presence or absence of H. pylori.	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Helicobacter Pylori; Chronic Gastritis; Heparanase
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Gastritis, Atrophic
• Other Study ID Numbers: Soh-Med-21-09-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No