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

Non-invasive measurement of hepatic fibrosis in children with cystic fibrosis - Liverfibrosis measurement in CF children

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31157

Enrollment

100

Registered

2007-11-27

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver fibrosis

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
CFTR mutation, pulmonary function (FEV1), nutritional status, pancreas insufficientie	—

Countries

Netherlands

Outcome results