Biliary Atresia Long-Term Observation: The BASIC Study

Biliary Atresia Study in Infants, Children and Adults

Protocol Description

The purpose of the multicenter Biliary Atresia Study in Infants, Children and Adults (BASIC) is to collect information on patients with biliary atresia so that researchers will be able to learn more about their long-term health following surgery to improve bile flow (Kasai procedure). Through this study, researchers will collect and store samples of blood and urine from children and adults with biliary atresia, and their parents, to be used in future research about liver disease and to help them learn more about the causes of biliary atresia. This study is an initiative of the Childhood Liver Disease Research Network (ChiLDReN).

Eligibility Criteria

Males and females, ages 6 months and older, who have a confirmed diagnosis of biliary atresia and who have had the Kasai procedure, are invited to participate in this research study. Biological parents are invited to voluntarily participate.
Males and Females: 6 months and older

Requirements

During the initial visit, researchers will gather medical history about the participant’s liver disease as well as blood and urine samples. Blood samples from parents will also be requested for analysis. Participants who have not had a liver transplant will be followed annually for 9 years with visits scheduled to coincide with the patient’s regularly scheduled follow-up for biliary atresia, when possible. For post-transplant patients, a single visit is required.
Visits: 9 annual visits; 1 for post-transplant patients
Duration: Up to 10 years for patients who have not had a liver transplant

Status: Open to Enrollment

Source(s) of Support

National Institute of Diabetes and Digestive and Kidney Diseases

Primary Investigator

Robert H. Squires, MD

Contact Information

For more information about the study or enrollment, please contact:
Maddie Schulte, RN
412-692-5811