Biliary Atresia
Conditions
Interventions
Steroid therapy Group:Methyllprednisolone
Control Group:Blank Control
Sponsors
Children's Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1. Within 72 hours Post-Kasai portoenterostomy for Type 3 biliary atresia; 2. Post-conception age older than 36 weeks, both genders; 3. Weight at enrolment more than 2kg; 4. Written informed consent to participate in the clinical trial obtained prior to or within 72 hours of completion of Kasai portoenterostomy.
Exclusion criteria
Exclusion criteria: 1. Known immunodeficiency; 2. Severe complications happen during or within 72 hours after Kasai procedure (e.g. massive hemorrhage, intestinal obstruction); 3. Diabetes mellitus or hypertension (persistent systolic blood pressure higher than 112 mmHg); 4. With hemolytic jaundice, a serum indirect bilirubin more than 85.5umol/L (5mg/dL) for infants under 4 weeks of age or more than 119.7umol/L (7mg/dL) for infants between 4 and 8 weeks of age; 5. Infants whose mother has known human immunodeficiency virus infection, or HbsAg or hepatitis C virus positive; 6. Known congenital infection with herpes simplex virus, toxoplasmosis etc.; 7. Known allergy to steroids or other adjuvant therapies; 8. With other severe concurrent illnesses that will interfere with the conduct and results of the study; 9. With any other clinical condition that is a contraindication to the use of steroids (e.g. bowel perforation); 10. Infants who have received the live attenuated rotavirus vaccine within 5 days prior to proposed administration of trial drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of jaundice clearance (serum total bilirubin less than 20 umol/L) at 6 months post-Kasai portoenterostomy;survival with native liver at 6 months post-Kasai portoenterostomy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function and serum total bilirubin concentration prior and at 1 month, 3 months, 12 months and 24 months post-Kasai portoenterstomy;survival with native liver at 24 months post-Kasai portoenterostomy;Growth at 12 and 24 months post-Kasai portoenterstomy;Percentage of adverse events at 1, 3, 6, 12, 24 months post-Kasai portoenterstomy; | — |
Countries
China
Contacts
Public ContactShan Zheng
Outcome results
None listed