Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

Biliary Atresia Clinical Trial

Official title:

Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652533
• Other study ID #: 2015-7320
• Status: Completed
• Start date: September 2016
• Est. completion date: July 2019

Study information

• Verified date: March 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

Device:
• Ultrasound Shear Wave Elastography
The investigators have recently published a very small study in neonates/infants with suspected BA showing that US liver shear wave speed (i.e. - liver stiffness) can differentiate BA from other causes of cholestasis, potentially with a very high degree of accuracy. Additional research is needed to confirm these very preliminary results and determine if liver shear wave speed measurements either before or after (including longitudinally) Kasai can predict key outcomes.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's	Columbus	Ohio
United States	Lucile Packard Children's Hospital/Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Siemens Medical Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrimination of biliary atresia from other liver diseases using ultrasound liver shear wave speed (Aim 1)	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	Predicting long term clinical outcomes in biliary atresia patients using ultrasound liver shear wave speed (aim 2)	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