Clinical Trial: Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia
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 Summary:
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.
Sponsor: Hannover Medical School
Current Primary Outcome: Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Jaundice free survival confirmed by serum bilirubin < 20 umol/l [ Time Frame: 6 months ]
- Feasibility of laparoscopic Kasai with regard to conversions and revisions [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Hannover Medical School
Dates:
Date Received: February 4, 2010
Date Started: August 2003
Date Completion:
Last Updated: February 4, 2010
Last Verified: December 2009
