ClinicalTrials.Veeva

Menu

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

H

Hannover Medical School (MHH)

Status

Completed

Conditions

Biliary Atresia

Treatments

Procedure: Laparoscopic Kasai operation

Study type

Interventional

Funder types

Other

Identifiers

NCT01063699
EBAR 9260

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

1 to 4 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Biliary atresia

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 1 patient group

Lap Kasai
Experimental group
Description:
Patients in this arm had their necessary Kasai procedure in a laparoscopic way.
Treatment:
Procedure: Laparoscopic Kasai operation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems