RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00539565

Enrollment

100

Registered

2007-10-04

Start date

2000-01-31

Completion date

2008-09-30

Last updated

2007-10-04

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

Conditions

Biliary Atresia

Keywords

biliary atresia, Kasai portoenterostomy, corticosteroids

Brief summary

Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.

Detailed description

Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile root of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in \ 50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.

Interventions

DRUGprednisolone

2 mg/kg /day from post-op day 7 - day 21 1 mg/kg /day from post-op day 22 - day 30

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 100 Days

Healthy volunteers

Inclusion criteria

* biliary atresia

Exclusion criteria

* \<100 days at portoenterostomy * no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome) * anu contra-indications to corticosteroids

Design outcomes

Primary

Measure	Time frame
clearance of jaundice (<20 umol/L)	1 year
Proportion transplanted or died	1 year

Secondary

Measure	Time frame
biochemical indices of liver function	1 year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026