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The Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trial

The Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015250
Enrollment
Unknown
Registered
2018-03-19
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

biliary atresia

Interventions

high-dose:UDCA 25mg/kg po
low-dose:UDCA 15mg/kg po

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) within 72 hours after Kasai procedure for type III biliary atresia; 2) The gestational age at birth is = 36 weeks, male or female; 3) Weight = 2kg when selected; 4) Family members understand and sign informed consent before or during Kasai surgery.

Exclusion criteria

Exclusion criteria: 1) There is a known immune deficiency; 2) Severe surgical complications (such as intestinal obstruction, massive bleeding, etc.) occur within 72 hours after surgery or within the postoperative period; 3) With diabetes or high blood pressure (systolic blood pressure persists =112mmHg); 4) Hemolytic jaundice, ie indirect bilirubin = 85.5 µmol/L (5 mg/dL) within 4 weeks of birth, or indirect bilirubin = 119.7 µmol/L (7 mg/dL) during 4-8 weeks of birth; 5) The mother suffers from human immunodeficiency disease, or is positive for HBsAg, or is positive for hepatitis C virus; 6) Incorporate other infections (such as herpes simplex virus, Toxoplasma gondii, etc.); 7) Severely allergic to steroids or other adjunctive therapies; 8) Consolidate other serious systemic diseases.

Design outcomes

Primary

MeasureTime frame
jaundice clearance rate ;native liver survival rate;

Secondary

MeasureTime frame
urinary component analysis;native liver survival rate;

Countries

China

Contacts

Public ContactZheng Shan

Children's Hospital of Fudan University

szheng@shmu.edu.cn+86 21 64931007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026