Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

September 19, 2019 updated by: Children's Hospital Medical Center, Cincinnati
The investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators plan a prospective, multi-center study to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation can discriminate biliary atresia (BA) from other causes of liver disease in the setting of neonatal cholestasis. The investigators also plan to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation or longitudinally during the first one-year period after Kasai can predict important long-term outcomes in BA patients.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Lucile Packard Children's Hospital/Stanford University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin >20% of total or ≥2 mg/dL age <3 months

Description

Inclusion Criteria:

  • neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin >20% of total or ≥2 mg/dL age <3 months

Exclusion Criteria:

  • inability to obtain parent/guardian consent.
  • inability to return for follow up visits as required by the study (these patients will be included in aim 1, but will be unable to participate in aim 2).
  • no other exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrimination of biliary atresia from other liver diseases using ultrasound liver shear wave speed (Aim 1)
Time Frame: 2 years
The primary outcome measure will be ultrasound shear wave speed of the liver. The investigators will compare the mean liver shear wave speed measurements in children with biliary atresia to other liver diseases. Sensitivity and specificity of ultrasound for diagnosing biliary atresia will be determined using multiple shear wave speed cut-off values.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicting long term clinical outcomes in biliary atresia patients using ultrasound liver shear wave speed (aim 2)
Time Frame: 6 years
Change in shear speed liver over time will be compared between children with biliary atresia versus other liver diseases in order to determine if differences predict important clinical outcomes.
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Siemens Medical Solutions

Investigators

  • Principal Investigator: Jonathan Dillman, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

January 8, 2016

First Posted (ESTIMATE)

January 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-7320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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