Hepatic Steatosis and Chronic Hepatitis B Virus

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05678582

Collaborator

(none)

Enrollment

Location

8.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis	Diagnostic Test: Liver biopsy

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

The Impact of Hepatic Steatosis on Chronic Hepatitis B Virus Infection

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
HBV with hepatic steatosis HBV with hepatic steatosis on liver biopsy	Diagnostic Test: Liver biopsy Ultrasound guided liver biopsy were taken then evaluated by histopathological examination
HBV without hepatic steatosis HBV without hepatic steatosis on liver biopsy	Diagnostic Test: Liver biopsy Ultrasound guided liver biopsy were taken then evaluated by histopathological examination

Arm

Intervention/Treatment

HBV with hepatic steatosis

HBV with hepatic steatosis on liver biopsy

Diagnostic Test: Liver biopsy

Ultrasound guided liver biopsy were taken then evaluated by histopathological examination

HBV without hepatic steatosis

HBV without hepatic steatosis on liver biopsy

Diagnostic Test: Liver biopsy

Ultrasound guided liver biopsy were taken then evaluated by histopathological examination

Outcome Measures

Primary Outcome Measures

prevalence of hepatic steatosis in CHB [January 2023 to july 2023 will be included in the study]
Number of cases with hepatic steotosis in CHB
degree of hepatic steatosis in CHB [January 2023 to july 2023 will be included in the study]
Mild, or Moderate or severe degree

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.