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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02603666
Recruitment Status : Completed
First Posted : November 13, 2015
Results First Posted : December 30, 2016
Last Update Posted : December 30, 2016
Karolinska Institutet
Information provided by (Responsible Party):
Ferenc Karpati, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Liver Fibrosis Device: Fibroscan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects
Study Start Date : January 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Fibroscan elastography device for evaluation of liver disease in CF patients.
Device: Fibroscan
Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.
Other Name: Elastography

Primary Outcome Measures :
  1. Elastographic Value in kPa Measured by Fibroscan [ Time Frame: Within 28 days in connection with their annual evaluation at a single point of time ]
    Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Verified cystic fibrosis

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02603666

Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
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Principal Investigator: Ferenc Karpati, MD, PhD Stockholm CF Center, Karolinska University Hospital
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Responsible Party: Ferenc Karpati, MD, PhD, Karolinska University Hospital Identifier: NCT02603666    
Other Study ID Numbers: 2010/1957/31/3
First Posted: November 13, 2015    Key Record Dates
Results First Posted: December 30, 2016
Last Update Posted: December 30, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ferenc Karpati, Karolinska University Hospital:
cystic fibrosis
liver biopsy
Additional relevant MeSH terms:
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Cystic Fibrosis
Liver Cirrhosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Liver Diseases