Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia

Study Overview
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Brief Summary
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This study evaluated laparoscopic (videosurgery) versus conventional (open surgery) Kasai portoenterostomy (anastomosis of small intestine to the liver hilus) in children with biliary atresia. The study was stopped due to lower survival with native liver 6 months after the laparoscopic operation. Follow-up after 24 months confirmed superior results after conventional operation.

Detailed Description
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Objective: A prospective observational study to compare survival with own liver in laparoscopic versus conventional Kasai portoenterostomy in patients with biliary atresia. Summary Background Data: Available studies on laparoscopic versus conventional Kasai portoenterostomy focus on short-term results, include limited numbers of patients and have design limitations. Methods: A consecutive series of patients underwent laparoscopic Kasai procedure from 2006 to 2007. Conventionally operated control patients consisted of a consecutive series of infants with biliary atresia operated from August 2003 to 2006. All data were ascertained prospectively using the European Biliary Atresia Registry / EBAR registration forms. Primary outcome measure was survival with own liver 6 months after Kasai without being listed for liver transplantation. An interim analysis was planned after data became available for the first 12 patients who underwent laparoscopic Kasai procedure. In case of a significantly different interim outcome the follow-up period should be extended to 24 months until a final decision should be drawn.

Official Title
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Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia

Conditions
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Biliary Atresia

Intervention / Treatment
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* Procedure: Laparoscopic Kasai operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biliary atresia Exclusion Criteria: < 3000 grs. body weight Syndromatic form of biliary atresia Significant comorbidity i.e. cardiac Contraindication to laparoscopy

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lap Kasai<br>Patients in this arm had their necessary Kasai procedure in a laparoscopic way. | Procedure: Laparoscopic Kasai operation<br>* the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.<br>* Other names: coelioscopie;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jaundice free survival confirmed by serum bilirubin < 20 umol/l |  | 6 months | 
| Feasibility of laparoscopic Kasai with regard to conversions and revisions |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biliary atresia - laparoscopy - kasai - portoenterostomy