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NCT Number: NCT06724731

Role of Combined Ultrasound Elastography in Evaluation the Degree of Liver Fibrosis in Children With Cholesteric Liver Disease

Pediatric CLDs are diverse, encompassing a broad spectrum of conditions, from congenital and metabolic disorders to autoimmune and viral diseases. These chronic liver conditions in children often carry the risk of progressing to fibrosis and cirrhosis. Additionally, certain liver diseases in children exhibit unique characteristics, including varying rates of fibrosis progression. For example, while fibrosis typically takes months to develop in most patients, it progresses much faster in neonates . Approximately 1%-2% of adults, but a significantly higher 17%-30% of children, progress to advanced liver disease and require liver transplantation annually.

the aim of the study to evaluate the diagnostic value of Combi-Elasto technique in detecting degree of liver fibrosis in children with Cholestatic Liver Disease

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

About this study

The prevalence of chronic liver disease (CLD) among children is on the rise globally, driven by various epidemiological shifts, such as the opioid crisis contributing to hepatitis C infections and the obesity epidemic leading to nonalcoholic fatty liver disease (NAFLD) . liver disease affects 1 in every 2,500 infants, and in 2021, children accounted for 13% of all liver transplants in the United States .

Currently, there are no effective pharmacological treatments to prevent or slow the progression of Cholestatic Liver Disease in children. As a result, it is crucial to evaluate the extent of liver fibrosis in children with cholestatic liver disease as early as possible. Early assessment is vital for delaying disease progression, decreasing the need for liver transplantation, and providing essential information for clinical decision-making when transplantation becomes necessary.

Combi-Elasto technique, which integrates elastography with other non-invasive imaging modalities, has emerged as a promising tool for evaluating liver fibrosis. This approach offers several potential benefits, including enhanced diagnostic accuracy, safety, and the ability to assess fibrosis without the need for invasive procedures. Combi-elasto (CE) integrates the benefits of both strain elastography and shear wave elastography. It uses the fibrosis index (FI), activity index (AI), and attenuation coefficient (ATT) to provide precise evaluations of fibrosis levels, inflammation activity, and fatty degeneration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be aged between 0 and 18 years at the time of enrollment.
  • Children must have a confirmed diagnosis of cholestatic liver disease, supported by:
  • Histological confirmation via liver biopsy showing cholestasis.
  • Clinical evidence of cholestasis, such as elevated alkaline phosphatase levels or conjugated hyperbilirubinemia.
  • Participants should have a documented history of cholestatic liver disease for at least three months prior to enrollment to ensure that the condition is chronic and allows for adequate assessment of fibrosis progression.

Exclusion criteria

  • patients without prehepatic ascites
  • patients with hepatic space-occupying lesions.
  • patients with other serious systemic diseases, such as heart failure, renal failure and mental illness
  • patients after liver transplantation.

Treatment and study plan

Primary outcomes

  1. the accuracy of the Combi-Elasto technique in determining the degree of liver fibrosis in children

    Time frame: baseline

    sensitivity, and specificity of the Combi-Elasto technique in determining the degree of liver fibrosis in children

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab Mohamed Abdo Hussien, resident doctor

CONTACT

[email protected]

+201014258087

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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