- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774601
Elastography in Chronic Liver Disease in Children
The Role of Ultrasound Elastography in the Assessment of Chronic Liver Disease in Children
Study Overview
Status
Conditions
Detailed Description
Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other, The term chronic liver disease (CLD) implies a long standing irreversible change in the hepatic structure that may end in complications like cirrhosis leading to premature death. While liver needle biopsy is still recognised to be the gold standard for the assessment of liver fibrosis in the diagnosis and follow-up of chronic liver diseases, researchers tend to study non-invasive methods in the determination of liver fibrosis, as liver needle biopsy is an invasive, painful and expensive procedure, which can cause possible sampling errors and potential complications , Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as it is non-invasive, cheap, feasible and available. Elastography, an ultrasonographic non-invasive procedure that measures tissue stiffness.
Liver fibrosis is a result of chronic damage, and attacks and remissions throughout the course of the disease trigger the formation of fibrosis. Apart from being a direct indicator of liver damage, fibrosis has an important role in the development of hepatocyte dysfunction and portal hypertension. In a clinical aspect, knowing the state and progress of fibrosis is important in the assessment of treatment response for the severity and the prognosis of the disease. The degree of fibrosis in the liver is important in the determination of prognosis, and management of the process in chronic liver disease. Patients with fibrosis benefit from treatment in case of early diagnosis.
Ultrasound Elastography is a non-invasive method.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mostafa Khalf, Resident
- Phone Number: 01550789590
- Email: mostafakhalf@icloud.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1 - all patients referred to the radiology department over the estimated period of the study. 2 - males and /or females from ( 0 to 18 years ) 3 - have clinical or laboratory or histopathological evidence of chronic liver disease 4 - had undergone liver biopsy.
Exclusion Criteria:
- - Patients males and or females older than 18 years
- - Patients who hadn't undergone liver biopsy previously
- - Patients with acute liver disease
- - Patients with human immune- deficiency virus (HIV) co infection.
- - patients with pacemaker (PM) or implantable cardioverter defibrillator (ICD) devices.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison the results of ultrasound elastography in chronic liver disease in children with histopathlogical findings .
Time Frame: Baseline
|
evaluate liver stiffness as a marker of severity and duration of the underlying chronic liver disease in children to achieve early diagnosis and benefit from treatment .
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Prof.Mostafa Thabet, Professor, Assiut University
- Study Chair: Prof.Mohamed koriem, Assistant professor, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Elastography in liver disease
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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