Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

Seyhmus Kavak

Status: Completed

Conditions: Fibrosis, Liver; Chronic Hepatitis B; Sonoelastography

Study type: Observational

Funder types: Other

Identifiers

NCT04759521

2019/215

Details and patient eligibility

About

The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in patients with CHB and determine the suitability of 2D-SWE for use instead of liver biopsy by evaluating fibrosis before and after treatment.

Full description

A total of 253 patients with CHB and inactive HBsAg carriers as well as a control group of 30 healthy individuals were included in the study between January 2019 and October 2020. Liver stiffness measurements with 2D-SWE, fibrosis-4 (FIB-4) and aspartate aminotransferase to platelet ratio index (APRI) scoring and additional liver biopsy in patients with CHB were performed in all cases with the help of the propagation map. Depending on the degree of fibrosis, liver stiffness was measured again at 24 and 48 weeks in patients who received antiviral therapy. Spearman rank correlation test was used for analysing correlation between variables, and receiver operating curve analysis was used to evaluate diagnostic performance in terms of fibrosis.

Enrollment: 253 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Being infected with the hepatitis B virus,
2. > 18 years old
3. < 64 years old

Exclusion criteria

1. Co-infection with hepatitis C or D
2. Have chronic or acute fulminant liver disease
3. Have DM disease
4. Hypertriglyceridemia, obesity, grade2 and higher hepatosteatosis,
5. Long-term drug use, alcohol intake that may damage the liver
6. Under the age of eighteen
7. Over sixty-five years old
8. Transplantation patients

Trial design

253 participants in 3 patient groups

Group 1

Description:

Inactive HBsAg carriers were patients with HBsAg positivity for more than 6 months

Group 2

Description:

Patients diagnosed with chronic hepatitis B were patients with HBsAg positivity for more than 6 months

Group 3

Description:

The control group was composed of healthy individuals who were not infected with hepatitis B virus and did not fit any exclusion criteria.