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

NCT ID: NCT02603666

Last Updated: 2016-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-06-30

Brief 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.

Detailed 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.

Conditions

Cystic Fibrosis; Liver Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Elastography

Fibroscan elastography device for evaluation of liver disease in CF patients.

Group Type: OTHER

Fibroscan

Intervention Type: DEVICE

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

Interventions

Fibroscan

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

Intervention Type: DEVICE

Other Intervention Names

Elastography

Eligibility Criteria

Inclusion Criteria

• Verified cystic fibrosis

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ferenc Karpati

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferenc Karpati, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stockholm CF Center, Karolinska University Hospital

Other Identifiers

2010/1957/31/3

Identifier Type: -

Identifier Source: org_study_id