Shear-wave Elastography Diffuse Liver Disease

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05163132

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatic Chronic Liver Disease and Cirrhosis	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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Outcome Measures

Primary Outcome Measures

Shearwave elastography (SWE) of the liver [1 week]
Analyze the correlation between SWE of liver and with computed tomography findings.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Abdel-Tawab Mohamed, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05163132

Other Study ID Numbers:

Fibroscan

First Posted:

Dec 20, 2021

Last Update Posted:

Jan 6, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Jan 6, 2022