Hepatic Steatosis and Chronic Hepatitis B Virus

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the prevalence and severity of hepatic steatosis in CHB and investigate the relationship between hepatic steatosis and viral load, liver biochemistry, liver fibrosis, and inflammation in CHB

Detailed Description
-----------------
This hospital-based cohort study will be conducted on 80 adult hepatitis B surface antigen (HBsAg) carriers presented to the Tropical Medicine and Gastroenterology outpatient clinic, at Sohag University Hospital Exclusion criteria Patients with serological evidence of HCV. HBV patients who had received or are currently under anti-viral therapy. Alcohol consumption. Decompensated liver disease. Patients with HCC. Patients are known to have another chronic liver disease (e.g. autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, Haemochromatosis, or drug-induced chronic hepatitis). Patients with contraindications to liver biopsy such as uncooperative patients, prothrombin time (PT) >4 seconds more than control, INR greater than 1.6, platelets count <100.000/mm3After taking informed written consent, the participants will be subjected to: Clinical evaluation: medical history and physical examination. Laboratory investigations: Complete blood count. Prothrombin time and concentration. Liver function tests Anti-HCV. HBeAg. HBV DNA. Abdominal ultrasonography Ultrasound-guided percutaneous liver biopsy

Official Title
-----------------
The Impact of Hepatic Steatosis on Chronic Hepatitis B Virus Infection

Conditions
-----------------
Chronic Hepatitis

Intervention / Treatment
-----------------
* Diagnostic Test: Liver biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis B surface antigen (HBsAg) carriers presented to the Tropical Medicine and Gastroenterology outpatient clinic, at Sohag University Hospital Exclusion Criteria: Patients with serological evidence of HCV. HBV patients who had received or are currently under anti-viral therapy. Alcohol consumption. Decompensated liver disease. Patients with HCC. Patients are known to have another chronic liver disease (e.g. autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, Haemochromatosis, or drug-induced chronic hepatitis). Patients with contraindications to liver biopsy such as uncooperative patients, prothrombin time (PT) >4 seconds more than control, INR greater than 1.6, platelets count <100.000/mm3.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HBV with hepatic steatosis<br>HBV with hepatic steatosis on liver biopsy | Diagnostic Test: Liver biopsy<br>* liver biopsy were taken then evaluated by histopathological examination<br>|
| HBV without hepatic steatosis<br>HBV without hepatic steatosis on liver biopsy | Diagnostic Test: Liver biopsy<br>* liver biopsy were taken then evaluated by histopathological examination<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of hepatic steatosis in CHB | Number of cases with hepatic steotosis in CHB | January 2023 to july 2023 will be included in the study | 
| degree of hepatic steatosis in CHB | Mild, or Moderate or severe degree | January 2023 to july 2023 will be included in the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV, Steatosis