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RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

NCT ID: NCT00539565

Last Updated: 2007-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Biliary Atresia

Keywords

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biliary atresia Kasai portoenterostomy corticosteroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

oral corticosteroids

Group Type ACTIVE_COMPARATOR

prednisolone

Intervention Type DRUG

2 mg/kg /day from post-op day 7 - day 21

1 mg/kg /day from post-op day 22 - day 30

B

as for active regimen

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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prednisolone

2 mg/kg /day from post-op day 7 - day 21

1 mg/kg /day from post-op day 22 - day 30

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

100 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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Mark Davenport, ChM

Role: PRINCIPAL_INVESTIGATOR

Kings College Hospital

Locations

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Kings College Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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KCH99LG21

Identifier Type: -

Identifier Source: org_study_id