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

This study has been completed.

Sponsor:

Information provided by:

Hannover Medical School

ClinicalTrials.gov Identifier:

NCT01063699

First received: February 4, 2010

Last updated: NA

Last verified: December 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 4, 2010

Last Updated Date

February 4, 2010

Start Date ^ICMJE

August 2003

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Jaundice free survival confirmed by serum bilirubin < 20 umol/l [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Feasibility of laparoscopic Kasai with regard to conversions and revisions [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Biliary Atresia

Intervention ^ICMJE

Procedure: Laparoscopic Kasai operation

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

Other Names:

hepatoportoenterostomy
coelioscopie

Study Arm (s)

Experimental: Lap Kasai

Patients in this arm had their necessary Kasai procedure in a laparoscopic way.

Intervention: Procedure: Laparoscopic Kasai operation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Biliary atresia

Exclusion Criteria:

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

Gender

Both

Ages

1 Month to 4 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01063699

Other Study ID Numbers ^ICMJE

EBAR 9260

Has Data Monitoring Committee

Yes

Responsible Party

Benno M Ure, Hannover Medical School

Study Sponsor ^ICMJE

Hannover Medical School

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Claus Petersen, Prof.

MHH pediatric surgery

Information Provided By

Hannover Medical School

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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