RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00539565
First received: October 3, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

October 3, 2007
October 3, 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
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
Both
up to 100 Days
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00539565
KCH99LG21
No
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