Cystic Fibrosis Clinical Trial
— CFALDOfficial title:
The Utility of Point Shear-wave Elastography to Assess for Hepatic & Pancreatic Fibrosis in Pediatric Cystic Fibrosis Patients
Diagnosis of hepatic fibrosis is challenging as specific tests for detection of fibrosis in pediatric Cystic Fibrosis associated liver disease (CFALD) have not been developed and existing investigations do not correlate well with presence or severity of disease. Using a Liver biopsy it is difficult to diagnose this condition because of the patchy nature of the disease. Investigators intend to identify hepatic and pancreatic fibrosis in Cystic Fibrosis patients using Elastography and correlate this with their biochemical markers as well as histological findings of patients who have undergone liver biopsy for diagnosis of CFALD.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | January 31, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Age <18 years - Confirmed diagnosis of cystic fibrosis attending Pediatric cystic fibrosis (CF) Clinic at Children's Hospital, Winnipeg. Exclusion Criteria: - Children with age >18 years |
Country | Name | City | State |
---|---|---|---|
Canada | Winnipeg Children's Hospital | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the diagnostic properties of Shear wave Elastography | To evaluate the diagnostic properties of Shear wave Elastography (ElastPQ) in children with CF for detection of liver fibrosis. Investigators will look at the values of shearwave elastography and see how it correlates with the fibrosis values obtained on liver biopsy as well as with AST/platelet ratio index |
6 months | |
Secondary | To compare findings/fibrosis of Transient Elastography vs ElastPQ | Investigators will compare degree of fibrosis on Transient Elastography vs Elast PQ to determine correlation .Some patients who have undergone liver biopsy will be correlated to liver fibrosis seen on biopsy. This will allow investigators to determine if Shear wave elastography can reliably detect fibrosis in patients with CFALD |
6 months | |
Secondary | To compare the pancreatic insufficiency/ fecal elastase and transient elastography from pancreas. | Investigators will see how well pancreatic fibrosis correlates with Fecal Elastase values and pancreatic endocrine function . This will let investigators know if Pancreatic elastography can help them in deciding which patients can have pancreatic insufficiency . |
6 months |
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