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

Not Applicable

Completed

• Conditions: Chronic Gastritis
• Interventions: Genetic: immunohistochemical detection of Heparanase in chronic gastritis

• Registration Number: NCT05073614
• Lead Sponsor: Sohag University

Brief Summary

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.

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 Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-11
• Primary Completion: 2021-12-30
• Status Verified: 2022-01
• Study Completion: 2022-01-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients with symptomatic chronic gastritis who underwent upper endoscopy.

Exclusion Criteria

• patients with gastric carcinoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with chronic gastritis	immunohistochemical detection of Heparanase in 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.

Primary Outcome Measures

Name	Time	Method
Correlation of Heparanase expression in chronic gastritis.	6 months	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.

Trial Locations

Locations (1)

Maisa Hashem Mohammed; 🇪🇬 Sohag, Egypt