RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

King's College Hospital NHS Trust

Status and phase: Unknown; Phase 3

Conditions: Biliary Atresia

Treatments: Drug: placebo; Drug: prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00539565

KCH99LG21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 100 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

oral corticosteroids

Treatment:

Drug: prednisolone

B

Placebo Comparator group

Description:

as for active regimen

Treatment:

Drug: placebo