Shear-wave Elastography Diffuse Liver Disease

Chronic Liver Disease and Cirrhosis Clinical Trial

Official title:

Correlation Between Shear-wave Elastography and CT in Diffuse Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05163132
• Other study ID #: Fibroscan
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: February 2023

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: Mohamed Abdeltawab, MD
• Phone: +201009319309
• Email: dr.m.tawab[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to correlate between quantitative results of shear wave elastography and CT picture in diffuse liver disease, including liver cirrhosis.

Description:

Many pathophysiological processes can lead to diffuse parenchymal liver diseases and the end-result of all chronic liver diseases is healing by fibrosis and regeneration. Liver fibrosis is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue ended with liver cirrhosis, with a variety of causes, including viral, drug induced, autoimmune, cholestatic, and metabolic diseases.

Liver biopsy is the gold standard but limited due to its invasiveness, sampling error, and intra- and interobserver variability. Non-invasive tests are preferred in the management of chronic liver diseases. Several serum tests for liver function and markers of liver fibrosis are available and have moderate sensitivity and specificity; however, they are confounded by a wide range of extra-hepatic diseases.

Currently, several methods are available for assessing hepatic fibrosis and progression of fibrogenesis including scintigraphy, magnetic resonance diffusion weighted imaging, and magnetic resonance spectroscopy could differentiate between cirrhosis or severe fibrosis and normal liver. However, an accurate staging of fibrosis or diagnosis of mild fibrosis was often not achievable. Shear-wave elastography (SWE) is a real-time freehand ultrasonography-based elastography method for liver stiffness measurement.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2023
• Est. primary completion date: January 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Both sexes are included: patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.

Exclusion Criteria:

• Lactating and pregnant women

• Patients known to had high serum creatinine

Related Conditions & MeSH terms

• Chronic Hepatic
• Chronic Liver Disease and Cirrhosis
• Liver Diseases

Intervention

Device:
• Shearwave elastography
Shear wave elastography is an ultrasound applied technique used to measure tissue stiffness as a result of a disease. So, it can be used to evaluate liver stiffness as a result of liver cirrhosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Boll DT, Merkle EM. Diffuse liver disease: strategies for hepatic CT and MR imaging. Radiographics. 2009 Oct;29(6):1591-614. doi: 10.1148/rg.296095513. — View Citation

Ferraioli G, Tinelli C, Dal Bello B, Zicchetti M, Filice G, Filice C; Liver Fibrosis Study Group. Accuracy of real-time shear wave elastography for assessing liver fibrosis in chronic hepatitis C: a pilot study. Hepatology. 2012 Dec;56(6):2125-33. doi: 10 — View Citation

Lingala S, Ghany MG. Natural History of Hepatitis C. Gastroenterol Clin North Am. 2015 Dec;44(4):717-34. doi: 10.1016/j.gtc.2015.07.003. Epub 2015 Aug 25. Review. — View Citation

Wilkins T, Akhtar M, Gititu E, Jalluri C, Ramirez J. Diagnosis and Management of Hepatitis C. Am Fam Physician. 2015 Jun 15;91(12):835-42. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shearwave elastography (SWE) of the liver	Analyze the correlation between SWE of liver and with computed tomography findings.	1 week