Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
NCT ID: NCT01063699
Last Updated: 2010-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2003-08-31
2007-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lap Kasai
Patients in this arm had their necessary Kasai procedure in a laparoscopic way.
Laparoscopic Kasai operation
the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.
Interventions
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Laparoscopic Kasai operation
the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Syndromatic form of biliary atresia
* Significant comorbidity i.e. cardiac
* Contraindication to laparoscopy
1 Month
4 Months
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Hannover Medical School
Principal Investigators
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Claus Petersen, Prof.
Role: STUDY_DIRECTOR
MHH pediatric surgery
Locations
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Hannover Medical School Pediatric Surgery Dpmt.
Hanover, Lower Saxony, Germany
Countries
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References
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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.
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.
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.
Other Identifiers
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EBAR 9260
Identifier Type: -
Identifier Source: org_study_id
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