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RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by King's College Hospital NHS Trust.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539565
First Posted: October 4, 2007
Last Update Posted: October 4, 2007
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.
Information provided by:
King's College Hospital NHS Trust
  Purpose
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.

Condition Intervention Phase
Biliary Atresia Drug: prednisolone Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • clearance of jaundice (<20 umol/L) [ Time Frame: 1 year ]
  • Proportion transplanted or died [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • biochemical indices of liver function [ Time Frame: 1 year ]

Estimated Enrollment: 100
Study Start Date: January 2000
Estimated Study Completion Date: September 2008
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539565


Locations
United Kingdom
Kings College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Mark Davenport, ChM Kings College Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00539565     History of Changes
Other Study ID Numbers: KCH99LG21
First Submitted: October 3, 2007
First Posted: October 4, 2007
Last Update Posted: October 4, 2007
Last Verified: September 2007

Keywords provided by King's College Hospital NHS Trust:
biliary atresia
Kasai portoenterostomy
corticosteroids

Additional relevant MeSH terms:
Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents