Survival with the native liver after laparoscopic versus conventional kasai portoenterostomy in infants with biliary atresia: a prospective trial.

OBJECTIVE: A prospective study to compare survival with own liver in laparoscopic versus conventional Kasai portoenterostomy in patients with biliary atresia.

BACKGROUND: Available studies on laparoscopic versus conventional Kasai portoenterostomy focus on short-term results, include small 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 the 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 can be made.

RESULTS: Twelve infants underwent laparoscopic Kasai procedure without conversion or revision and there was no revision in the control group of 28 conventionally operated patients. Six months after operation, 5 of 12 laparoscopically operated patients (42%) survived with own liver, compared with 23 of 28 (82%) controls (P < 0.01). The study was stopped due to the significantly higher rate of liver transplantation after laparoscopic operation. Ten patients (83%) after laparoscopic Kasai versus 18 (64%) conventionally operated patients were transplanted after 24 months (P < 0.05) and survival rates with own liver and serum bilirubin <20 μmol/L were 1 (8%) versus 8 (29%), respectively (P < 0.05).

CONCLUSIONS: This prospective study shows that the laparoscopic Kasai procedure for biliary atresia is technically feasible. However, the study was stopped after inclusion of 12 laparoscopically operated infants due to a lower survival with the native liver after laparoscopic versus conventional Kasai operation. Superior results after conventional operation were confirmed at follow-up after 24 months. Study registration ID: EBAR 9260/NCT01063699.