Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects

Cystic Fibrosis Clinical Trial

Official title:

Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603666
• Other study ID #: 2010/1957/31/3
• Status: Completed
• Phase: N/A
• First received: May 4, 2015
• Last updated: November 10, 2015
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological evaluation of liver biopsy if present.

Description:

There are 209 CF patients attending Stockholm Cystic Fibrosis Center (January 2010). All up till 15 years of age are screened for liver disease annually by ultrasound (US) and also by biochemical markers. Ultrasound is performed every third year over 15 years of age in patients without CFLD, while all of them with diagnosed CFLD are continued to be investigated annually. Biochemical markers are controlled at least once every year in all CF patients. Elastography of the liver will be planned together with the investigations of the annual follow up, in an optimal clinical status. If either US or elastography of the liver indicates liver disease or progress of the already existing pathological changes, a liver biopsy will be performed according to routine procedure at Stockholm CF Centre. Also, historical data of liver biopsies and biochemical investigations will be considered in the study.

Elastography of the liver will be performed by Fibroscan device, with transducers for children and adults, respectively.

Clinical importance Liver US investigations in CF patients have important implications but are difficult to standardize in a routine clinical setting. Elastography may have an advantage in the evaluation of early fibrosis with clinical importance in pursuing diagnostics and intensifying treatment. A significant group (up to 25 %) of CF patients may be helped by this novel method. Including histological data, accuracy of elastography in CF patients may be improved. Further details of the importance of fatty acid status in CF may be elucidated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Verified cystic fibrosis

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Liver Fibrosis

Intervention

Device:
• Fibroscan
Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fibrosis measured by elastography	Elastographic values given by Fibroscan	Participants will be followed within 28 days in connection with their annual evaluation at a single point of time	No