RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

October 3, 2007 updated by: King's College Hospital NHS Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
oral corticosteroids
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 Comparator: B
as for active regimen
Drug: placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
biochemical indices of liver function
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Investigators

  • Principal Investigator: Mark Davenport, ChM, Kings College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

October 3, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Estimate)

October 4, 2007

Last Update Submitted That Met QC Criteria

October 3, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCH99LG21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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