Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Biliary Atresia Bile Duct Diseases Biliary Tract Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Lucile Packard Children's Hospital/Stanford University, Stanford, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound shear wave elastography

Device

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

Siemens Medical Solutions

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jan 12, 2016
Registry last updated: Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed