RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539565
Recruitment Status : Unknown
Verified September 2007 by King's College Hospital NHS Trust.
Recruitment status was:  Enrolling by invitation
First Posted : October 4, 2007
Last Update Posted : October 4, 2007
Information provided by:
King's College Hospital NHS Trust

October 3, 2007
October 4, 2007
October 4, 2007
January 2000
Not Provided
  • clearance of jaundice (<20 umol/L) [ Time Frame: 1 year ]
  • Proportion transplanted or died [ Time Frame: 1 year ]
Same as current
No Changes Posted
biochemical indices of liver function [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Biliary Atresia
  • Drug: prednisolone

    2 mg/kg /day from post-op day 7 - day 21

    1 mg/kg /day from post-op day 22 - day 30

  • Drug: placebo
  • Active Comparator: A
    oral corticosteroids
    Intervention: Drug: prednisolone
  • Placebo Comparator: B
    as for active regimen
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2008
Not Provided

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
Sexes Eligible for Study: All
up to 100 Days   (Child)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Not Provided
King's College Hospital NHS Trust
Not Provided
Principal Investigator: Mark Davenport, ChM Kings College Hospital
King's College Hospital NHS Trust
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP