Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

NCT04759521 | Completed

• 1 other identifier: 2019/215
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B; Sonoelastography; Fibrosis, Liver

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison of liver stiffness levels of group 1 and group 2 patients

  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.

  1st week, 24th week and 48th week

Study Arms (3)

Group 1

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

Group 2

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

Group 3

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 253 patients with CHB and inactive hepatitis B surface antigen (HBsAg) carriers who presented to the Infectious Diseases outpatient clinic were included in the study. In addition, a healthy control group of 30 people was included.

You may qualify if:

• Being infected with the hepatitis B virus,
• \> 18 years old
• \< 64 years old

You may not qualify if:

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

Sponsors & Collaborators

• Seyhmus Kavak: lead

Study Sites (1)

Sağlik Bilimleri Üniversitesi Training and Research Hospital

Diyarbakır, 21600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Liver Cirrhosis; Hepatitis, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Radiologist

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 18, 2021
• Study Start: January 3, 2019
• Primary Completion: October 30, 2020
• Study Completion: December 18, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

TU (1)