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

Biliary Atresia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063699
• Other study ID #: EBAR 9260
• Status: Completed
• Phase: N/A
• First received: February 4, 2010
• Last updated: February 4, 2010
• Start date: August 2003
• Est. completion date: September 2007

Study information

• Verified date: December 2009
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 4 Months

Eligibility

Inclusion Criteria:

• Biliary atresia

Exclusion Criteria:

• < 3000 grs. body weight

• Syndromatic form of biliary atresia

• Significant comorbidity i.e. cardiac

• Contraindication to laparoscopy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

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

Locations

Country	Name	City	State
Germany	Hannover Medical School Pediatric Surgery Dpmt.	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. Epub 2005 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation		one year	No
Secondary	Jaundice free survival confirmed by serum bilirubin < 20 umol/l		6 months	No
Secondary	Feasibility of laparoscopic Kasai with regard to conversions and revisions		3 months	Yes

External Links

•   department information on biliary atresia treatment