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NCT Number: NCT01063699

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

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.

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Key information

Conditions

Biliary Atresia Bile Duct Diseases Biliary Tract Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Age range

1 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School Pediatric Surgery Dpmt.

Hanover, Lower Saxony, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biliary atresia

Exclusion criteria

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

Treatment and study plan

Laparoscopic Kasai operation

Procedure

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

Other names: hepatoportoenterostomy, coelioscopie

Primary outcomes

  1. Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation

    Time frame: one year

Secondary outcomes

  1. Jaundice free survival confirmed by serum bilirubin < 20 umol/l

    Time frame: 6 months

  2. Feasibility of laparoscopic Kasai with regard to conversions and revisions

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Feb 5, 2010
Registry last updated
Feb 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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