Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
Primary Purpose
Biliary Atresia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Laparoscopic Kasai operation
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Atresia focused on measuring biliary atresia - laparoscopy - kasai - portoenterostomy
Eligibility Criteria
Inclusion Criteria:
- Biliary atresia
Exclusion Criteria:
- < 3000 grs. body weight
- Syndromatic form of biliary atresia
- Significant comorbidity i.e. cardiac
- Contraindication to laparoscopy
Sites / Locations
- Hannover Medical School Pediatric Surgery Dpmt.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lap Kasai
Arm Description
Patients in this arm had their necessary Kasai procedure in a laparoscopic way.
Outcomes
Primary Outcome Measures
Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation
Secondary Outcome Measures
Jaundice free survival confirmed by serum bilirubin < 20 umol/l
Feasibility of laparoscopic Kasai with regard to conversions and revisions
Full Information
NCT ID
NCT01063699
First Posted
February 4, 2010
Last Updated
February 4, 2010
Sponsor
Hannover Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01063699
Brief Title
Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
Official Title
Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Atresia
Keywords
biliary atresia - laparoscopy - kasai - portoenterostomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lap Kasai
Arm Type
Experimental
Arm Description
Patients in this arm had their necessary Kasai procedure in a laparoscopic way.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Kasai operation
Other Intervention Name(s)
hepatoportoenterostomy, coelioscopie
Intervention Description
the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.
Primary Outcome Measure Information:
Title
Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation
Time Frame
one year
Secondary Outcome Measure Information:
Title
Jaundice free survival confirmed by serum bilirubin < 20 umol/l
Time Frame
6 months
Title
Feasibility of laparoscopic Kasai with regard to conversions and revisions
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biliary atresia
Exclusion Criteria:
< 3000 grs. body weight
Syndromatic form of biliary atresia
Significant comorbidity i.e. cardiac
Contraindication to laparoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Petersen, Prof.
Organizational Affiliation
MHH pediatric surgery
Official's Role
Study Director
Facility Information:
Facility Name
Hannover Medical School Pediatric Surgery Dpmt.
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
13672695
Citation
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.
Results Reference
background
PubMed Identifier
16341535
Citation
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.
Results Reference
background
PubMed Identifier
21475026
Citation
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.
Results Reference
derived
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Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
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