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

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.

• Laparoscopic Kasai operation (Procedure), also known as hepatoportoenterostomy, coelioscopie: the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.

Primary outcomes

• Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation [one year]

Secondary outcomes

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

Sex: All, ages: 1 Month to 4 Months

Inclusion Criteria:

* Biliary atresia

Exclusion Criteria:

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

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• 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. PMID 16341535
• Results publication: 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. PMID 21475026

• Claus Petersen, Prof., Study director, MHH pediatric surgery