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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   up to 100 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00539565     History of Changes
Other Study ID Numbers: KCH99LG21
Study First Received: October 3, 2007
Last Updated: October 3, 2007
Health Authority: United Kingdom: Research Ethics Committee

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
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 21, 2014