RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

Biliary Atresia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00539565
• Other study ID #: KCH99LG21
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: October 3, 2007
• Last updated: October 3, 2007
• Start date: January 2000
• Est. completion date: September 2008

Study information

• Verified date: September 2007
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

Drug:
• prednisolone
2 mg/kg /day from post-op day 7 - day 21 1 mg/kg /day from post-op day 22 - day 30
• placebo

Locations

Country	Name	City	State
United Kingdom	Kings College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clearance of jaundice (<20 umol/L)		1 year
Primary	Proportion transplanted or died		1 year
Secondary	biochemical indices of liver function		1 year