NCT01063699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
Last Updated

February 5, 2010

Status Verified

December 1, 2009

Enrollment Period

4.1 years

First QC Date

February 4, 2010

Last Update Submit

February 4, 2010

Conditions

Biliary Atresia

Keywords

biliary atresia - laparoscopy - kasai - portoenterostomy

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (2)

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

    6 months

  • Feasibility of laparoscopic Kasai with regard to conversions and revisions

    3 months

Study Arms (1)

Lap Kasai

EXPERIMENTAL

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

Procedure: Laparoscopic Kasai operation

Interventions

Laparoscopic Kasai operationPROCEDURE

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

Also known as: hepatoportoenterostomy, coelioscopie
Lap Kasai

Eligibility Criteria

Age1 Month - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Biliary atresia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School Pediatric Surgery Dpmt.

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (3)

  • 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. doi: 10.2170/jjphysiol.9.228. No abstract available.

    PMID: 13672695BACKGROUND

  • 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. doi: 10.1007/s00383-005-1609-0. Epub 2005 Dec 8.

    PMID: 16341535BACKGROUND

  • Ure BM, Kuebler JF, Schukfeh N, Engelmann C, Dingemann J, Petersen C. Survival with the native liver after laparoscopic versus conventional kasai portoenterostomy in infants with biliary atresia: a prospective trial. Ann Surg. 2011 Apr;253(4):826-30. doi: 10.1097/SLA.0b013e318211d7d8.

    PMID: 21475026DERIVED

MeSH Terms

Conditions

Biliary Atresia

Interventions

Portoenterostomy, Hepatic

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeBiliary Tract Surgical ProceduresDigestive System Surgical Procedures

Study Officials

  • Claus Petersen, Prof.

    MHH pediatric surgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

August 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 5, 2010

Record last verified: 2009-12

Locations

DE(1)