RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
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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 |
- clearance of jaundice (<20 umol/L) [ Time Frame: 1 year ]
- Proportion transplanted or died [ Time Frame: 1 year ]
- 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 |
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 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 June 18, 2013