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-OMON31919

Enrollment

100

Registered

2008-01-29

Start date

2007-12-01

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

12 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