Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

February 15, 2021 updated by: Seyhmus Kavak

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

253

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Diyarbakır, Turkey, 21600
        • Sağlik Bilimleri Üniversitesi Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of liver stiffness levels of group 1 and group 2 patients
Time Frame: 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.
1st week, 24th week and 48th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seyhmus Kavak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2019

Primary Completion (ACTUAL)

October 30, 2020

Study Completion (ACTUAL)

December 18, 2020

Study Registration Dates

First Submitted

February 13, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (ACTUAL)

February 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/215

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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