Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

Completed

• Conditions: Fibrosis, Liver; Chronic Hepatitis B; Sonoelastography

• Registration Number: NCT04759521
• Lead Sponsor: Seyhmus Kavak

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.

Study Timeline

• Study Start: 2019-01-03
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-18
• Status Verified: 2021-02
• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sağlik Bilimleri Üniversitesi Training and Research Hospital; 🇹🇷 Diyarbakır, Turkey