Back to resultsRCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
Primary Purpose
Biliary Atresia
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
prednisolone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Atresia focused on measuring biliary atresia, Kasai portoenterostomy, corticosteroids
Eligibility Criteria
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
Sites / Locations
- Kings College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
oral corticosteroids
as for active regimen
Outcomes
Primary Outcome Measures
clearance of jaundice (<20 umol/L)
Proportion transplanted or died
Secondary Outcome Measures
biochemical indices of liver function
Full Information
NCT ID
NCT00539565
First Posted
October 3, 2007
Last Updated
October 3, 2007
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00539565
Brief Title
RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
Official Title
Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Atresia
Keywords
biliary atresia, Kasai portoenterostomy, corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
oral corticosteroids
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
as for active regimen
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Description
2 mg/kg /day from post-op day 7 - day 21
1 mg/kg /day from post-op day 22 - day 30
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
clearance of jaundice (<20 umol/L)
Time Frame
1 year
Title
Proportion transplanted or died
Time Frame
1 year
Secondary Outcome Measure Information:
Title
biochemical indices of liver function
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Davenport, ChM
Organizational Affiliation
Kings College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
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