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FibroScan™ in Pediatric Cholestatic Liver Disease Study Protocol

Descriptive Information
Brief Title † FibroScan™ in Pediatric Cholestatic Liver Disease Study Protocol
Official Title † Childhood Liver Disease Research Network (ChiLDReN): FibroScan™ in Pediatric Cholestatic Liver Disease Study Protocol
Brief Summary Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and quantify liver fibrosis.
Detailed Description Noninvasive monitoring of liver fibrosis is an unmet and critical need within the clinical management of children with chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation of children with liver disease, subsequent surveillance liver biopsy is rarely performed in children because of its inherent invasiveness and risks. Therefore, our understanding of the natural history of fibrosis progression in children is limited. The patchy nature of fibrosis in many important pediatric liver diseases [e.g. biliary atresia (BA) and cystic fibrosis liver disease (CFLD)] limits the utility of sequential liver biopsy even if it were to be employed in clinical practice in pediatrics. Thus, non-invasive means of assessing liver fibrosis throughout the liver would be highly desirable and clinically useful in pediatric hepatology. ChiLDReN is poised and uniquely qualified to conduct a comprehensive longitudinal assessment of the utility of FibroScan™-specific elastography, liver stiffness measurement (LSM) as a measure of hepatic fibrosis in children with serious chronic cholestatic liver disease.
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Compare the distribution of LSM at enrollment between participants with and without portal hypertension
Secondary Outcome Measure † Change in Liver Stiffness Measurement (LSM) obtained via transient elastography from baseline to LSM at the Year 1 and Year 2 visits in participants with biliary atresia (BA).
Condition † Biliary Atresia Alagille Syndrome Alpha1 Anti-Trypsin Deficiency Portal Hypertension Liver Fibrosis Cholestasis
Intervention † OtherLiver Stiffness Measurement (LSM)
Study Arms / Comparison Groups All Subjects All subjects will be recruited from the Children parent studies: LOGIC (NCT00571272), BASIC (NCT00345553) and PROBE (NCT00061828) and will undergo Liver Stiffness Measurement (LSM). Subjects in these studies have one or more of the following conditions: biliary atresia (BA), Alpha1 Anti-trypsin Deficiency (A1AT) or Alagille Syndrome (ALGS).
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 450
Start Date † November 16, 2016
Completion Date September 2020
Primary Completion Date January 2019
Eligibility Criteria † Inclusion Criteria: - Age less than 21 years at the time of enrollment - Participants enrolled in a ChiLDReN based prospective observational cohort study (PROBE, BASIC, or LOGIC) - Willingness and ability to participate in the study for up to 24 months - One of the following three diagnoses - Biliary atresia per ChiLDReN criteria or, - Alpha-1 antitrypsin deficiency (PiZZ or SZ) or, - Alagille Syndrome per ChiLDReN criteria Exclusion Criteria: - BA with known situs inversus or polysplenia/asplenia - Presence of clinically significant ascites detected on physical examination - Open wound near expected FibroScan probe application site - Use of implantable active medical device such as a pacemaker or defibrillator - Known pregnancy - Prior liver transplant - Unable or unwilling to give informed consent or assent
Gender All
Ages N/A - 21 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Canada
Administrative Information
NCT ID † NCT02922751
Organization ID ChiLDReN FORCE Protocol
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ††
Investigators † Principal Investigator: Benjamin Shneider, MD, Texas Children's Hospital
Information Provided By
Verification Date February 2017
First Received Date † September 20, 2016
Last Updated Date February 6, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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