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

Not Applicable

Completed

• Conditions: Biliary Atresia
• Interventions: Procedure: Laparoscopic Kasai operation

• Registration Number: NCT01063699
• Lead Sponsor: Hannover Medical School

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-12
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Last Update Submitted: 2010-02-04
• Study First Posted: 2010-02-05
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Biliary atresia

Exclusion Criteria

• < 3000 grs. body weight
• Syndromatic form of biliary atresia
• Significant comorbidity i.e. cardiac
• Contraindication to laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lap Kasai	Laparoscopic Kasai operation	Patients in this arm had their necessary Kasai procedure in a laparoscopic way.

Primary Outcome Measures

Name	Time	Method
Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation	one year

Secondary Outcome Measures

Name	Time	Method
Jaundice free survival confirmed by serum bilirubin < 20 umol/l	6 months
Feasibility of laparoscopic Kasai with regard to conversions and revisions	3 months

Trial Locations

Locations (1)

Hannover Medical School Pediatric Surgery Dpmt.; 🇩🇪 Hannover, Lower Saxony, Germany