on-invasive measurement of hepatic fibrosis in children with cystic fibrosis

• Conditions: liver fibrosis; 10018012

• Registration Number: NL-OMON31919
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Children with cystic fibrosis treated in the Erasmus Medical Centre Rotterdam / Sophia Children's Hospital, age 2 - 18 years, written informed consent.

Exclusion Criteria

Age 0 - 2 year, measurement with Fibroscan is not feasible, as a result of small intercostal margins and/or ascits

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study outcome: liver-elasticity (as measured by Fibroscan): in kPA,<br /><br>related to: ultrasonography of the liver (liver parenchyma, intra- and<br /><br>extrahepatic biliary tree, portal vein, presence of collateral circulation,<br /><br>splenomegaly, flow direction in portal vein) , and related to biochemical<br /><br>markers: cholestasis (elevated blirubin, gamma-GT, alkaline phosphatase) or<br /><br>hepatitis (elevated serum transaminase levels). and liver function tests:<br /><br>prothrombin time, albumin. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>CFTR mutation, pulmonary function (FEV1), nutritional status, pancreas<br /><br>insufficientie </p><br>