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NCT Number: NCT04759521

Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sağlik Bilimleri Üniversitesi Training and Research Hospital

Diyarbakır, 21600, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seyhmus Kavak

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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