Elastography in Chronic Liver Disease in Children

Chronic Liver Disease Clinical Trial

Official title:

The Role of Ultrasound Elastography in the Assessment of Chronic Liver Disease in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04774601
• Other study ID #: Elastography in liver disease
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: September 2023

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: Mostafa Khalf, Resident
• Phone: 01550789590
• Email: mostafakhalf[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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,, 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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:

1. - Patients males and or females older than 18 years

2. - Patients who hadn't undergone liver biopsy previously

3. - Patients with acute liver disease

4. - Patients with human immune- deficiency virus (HIV) co infection.

5. - patients with pacemaker (PM) or implantable cardioverter defibrillator (ICD) devices.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Sönmez S, Bosat M, Yurtseven N, Yurtseven E. The role of elastography in the assessment of chronic liver disease in children. Afr Health Sci. 2019 Sep;19(3):2806-2811. doi: 10.4314/ahs.v19i3.57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison the results of ultrasound elastography in chronic liver disease in children with histopathlogical findings .	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