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

NCT02603666 | Completed Results

• 1 other identifier: 2010/1957/31/3
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis; Liver Fibrosis

Keywords

cystic fibrosis; elastography; liver biopsy

Outcome Measures

Primary Outcomes (1)

• Elastographic Value in kPa Measured by Fibroscan

  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.

  Within 28 days in connection with their annual evaluation at a single point of time

Study Arms (1)

Elastography

OTHER

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

Device: Fibroscan

Interventions

Fibroscan DEVICE

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

Also known as: Elastography

Elastography

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Verified cystic fibrosis

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

MeSH Terms

Conditions

Cystic Fibrosis; Liver Cirrhosis

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Ferenc Karpati M.D., Ph.D., Senior Consultant
• Organization: Karolinska University Hospital, Huddinge, 141 86 Stockholm

ferenc.karpati@karolinska.se

+46858580000

Study Officials

• Ferenc Karpati, MD, PhD

  Stockholm CF Center, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: November 13, 2015
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 30, 2016
• Results First Posted: December 30, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share