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

Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01063699
Enrollment
56
Registered
2010-02-05
Start date
2003-08-31
Completion date
2007-09-30
Last updated
2010-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia

Keywords

biliary atresia - laparoscopy - kasai - portoenterostomy

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.

Interventions

PROCEDURELaparoscopic Kasai operation

the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 4 Months
Healthy volunteers
No

Inclusion criteria

* Biliary atresia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantationone year

Secondary

MeasureTime frame
Jaundice free survival confirmed by serum bilirubin < 20 umol/l6 months
Feasibility of laparoscopic Kasai with regard to conversions and revisions3 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026