Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

Evaluation of Liver Fibrosis in Chronic Hepatitis B Patients With 2D Shear Wave Elastography With Propagation Map: A Single Center Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04759521

Enrollment

253

Registered

2021-02-18

Start date

2019-01-03

Completion date

2020-12-18

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B, Fibrosis, Liver, Sonoelastography

Keywords

Shear wave elastography, Propagation map, Chronic Hepatitis, Liver fibrosis

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of liver stiffness levels of group 1 and group 2 patients	1st week, 24th week and 48th week	Liver stiffness levels of group 1 and group 2 patients were compared by measuring in kPa and m / s using 2D-SWE technique. Possible increase and decrease values in liver stiffness measurements were calculated at 24 and 48 weeks in subjects who received antiviral therapy.

Countries

Turkey (Türkiye)

Outcome results