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FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

NCT02922751 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 552

Last updated 2024-08-28

No results posted yet for this study

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.

Conditions

  • Biliary Atresia
  • Alagille Syndrome
  • Alpha1 Anti-Trypsin Deficiency
  • Portal Hypertension
  • Liver Fibrosis
  • Cholestasis

Interventions

OTHER

Liver Stiffness Measurement (LSM)

LSM will be measured via transient elastography utilizing the non-invasive FibroScan™ ultrasound device. LSM will be measured at Baseline, Year 1 and Year 2 visits.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Arbor Research Collaborative for Health

    lead OTHER

Principal Investigators

  • Benjamin Shneider, MD · Baylor College of Medicine

  • Ed Doo, MD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Averell Sherker, MD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • John Magee, MD · University of Michigan Medical Center, Ann Arbor

  • Lisa Henn, PhD · Arbor Research Collaborative of Health

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2022-12-22
Completion
2022-12-22

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02922751 on ClinicalTrials.gov