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CompletedNCT04759521

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
Phase
Study type
Observational
Enrollment
253 (actual)
Sponsor
Seyhmus Kavak · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2019-01-03
Primary completion
2020-10-30
Completion
2020-12-18
First posted
2021-02-18
Last updated
2021-02-18

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04759521. Inclusion in this directory is not an endorsement.

Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography (NCT04759521) · Clinical Trials Directory