Shear-wave Elastography Diffuse Liver Disease

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Liver Disease and Cirrhosis; Chronic Hepatic
• Intervention / Treatment: Device: Shearwave elastography

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Mohamed Abdeltawab, MD; Phone Number: +20 +201009319309; Email: dr.m.tawab@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shearwave elastography (SWE) of the liver	Analyze the correlation between SWE of liver and with computed tomography findings.	1 week

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed Abdeltawab, MD, assiut; Principal Investigator: Hayam M Abd El-hakeem, Assiut University; Study Chair: Eman Abo El-hamd, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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: 10.1002/hep.25936. Epub 2012 Aug 31.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: FibroScan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No