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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01063699
First Posted: February 5, 2010
Last Update Posted: February 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hannover Medical School
  Purpose
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.

Condition Intervention
Biliary Atresia Procedure: Laparoscopic Kasai operation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation [ Time Frame: one year ]

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

Enrollment: 56
Study Start Date: August 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lap Kasai
Patients in this arm had their necessary Kasai procedure in a laparoscopic way.
Procedure: Laparoscopic Kasai operation
the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.
Other Names:
  • hepatoportoenterostomy
  • coelioscopie

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biliary atresia

Exclusion Criteria:

  • < 3000 grs. body weight
  • Syndromatic form of biliary atresia
  • Significant comorbidity i.e. cardiac
  • Contraindication to laparoscopy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063699


Locations
Germany
Hannover Medical School Pediatric Surgery Dpmt.
Hannover, Lower Saxony, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Study Director: Claus Petersen, Prof. MHH pediatric surgery
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benno M Ure, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01063699     History of Changes
Other Study ID Numbers: EBAR 9260
First Submitted: February 4, 2010
First Posted: February 5, 2010
Last Update Posted: February 5, 2010
Last Verified: December 2009

Keywords provided by Hannover Medical School:
biliary atresia - laparoscopy - kasai - portoenterostomy

Additional relevant MeSH terms:
Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities