Clinical trial NCT01063699: Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
Official title: Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Atresia
Keywords: biliary atresia - laparoscopy - kasai - portoenterostomy
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Biliary atresia

Exclusion Criteria:

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

Primary outcomes:
measure: Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation
timeFrame: one year
Secondary outcomes:
measure: Jaundice free survival confirmed by serum bilirubin < 20 umol/l
timeFrame: 6 months
measure: Feasibility of laparoscopic Kasai with regard to conversions and revisions
timeFrame: 3 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School Pediatric Surgery Dpmt.
state: Lower Saxony
Study officials:
affiliation: MHH pediatric surgery
name: Claus Petersen, Prof.
role: STUDY_DIRECTOR
References:
citation: FUJINO M, KASAI K, KOSEKI A. The effects of temperature on actomyosin adenosinetriphosphatase activity and super-precipitation. Jpn J Physiol. 1959 Jun 25;9(2):228-38. doi: 10.2170/jjphysiol.9.228. No abstract available.
citation: Okazaki T, Miyano G, Yamataka A, Kobayashi H, Koga H, Lane GJ, Miyano T. Diagnostic laparoscopy-assisted cholangiography in infants with prolonged jaundice. Pediatr Surg Int. 2006 Feb;22(2):140-3. doi: 10.1007/s00383-005-1609-0. Epub 2005 Dec 8.
citation: Ure BM, Kuebler JF, Schukfeh N, Engelmann C, Dingemann J, Petersen C. Survival with the native liver after laparoscopic versus conventional kasai portoenterostomy in infants with biliary atresia: a prospective trial. Ann Surg. 2011 Apr;253(4):826-30. doi: 10.1097/SLA.0b013e318211d7d8.