Clinical trial NCT05163132: Shear-wave Elastography Diffuse Liver Disease
Official title: Correlation Between Shear-wave Elastography and CT in Diffuse Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatic
Chronic Liver Disease and Cirrhosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shearwave elastography (SWE) of the liver
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut
name: Mohamed Abdeltawab, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Hayam M Abd El-hakeem
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Eman Abo El-hamd
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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: 10.1002/hep.25936. Epub 2012 Aug 31.