Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia|
- Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation [ Time Frame: one year ] [ Designated as safety issue: No ]
- Jaundice free survival confirmed by serum bilirubin < 20 umol/l [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Feasibility of laparoscopic Kasai with regard to conversions and revisions [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2003|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Experimental: Lap Kasai
Patients in this arm had their necessary Kasai procedure in a laparoscopic way.
Procedure: Laparoscopic Kasai operation
the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063699
|Hannover Medical School Pediatric Surgery Dpmt.|
|Hannover, Lower Saxony, Germany, 30625|
|Study Director:||Claus Petersen, Prof.||MHH pediatric surgery|