FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)



Status:Enrolling by invitation
Conditions:High Blood Pressure (Hypertension), Gastrointestinal, Gastrointestinal, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:Any - 21
Updated:2/24/2019
Start Date:November 16, 2016
End Date:January 2022

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Childhood Liver Disease Research Network (ChiLDReN): FibroScan™ in Pediatric Cholestatic Liver Disease Study Protocol

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.

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.

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
We found this trial at
13
sites
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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Cincinnati, OH
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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555 University Avenue
Toronto, Ontario M5G 1X8
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Toronto,
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