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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lap Kasai | Experimental | Patients in this arm had their necessary Kasai procedure in a laparoscopic way. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Kasai operation | Procedure | the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Jaundice free survival confirmed by serum bilirubin < 20 umol/l | 6 months | |
| Feasibility of laparoscopic Kasai with regard to conversions and revisions | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Petersen, Prof. | MHH pediatric surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School Pediatric Surgery Dpmt. | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13672695 | Background | 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. | |
| 16341535 | Background | 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. |
| Label | URL |
|---|---|
| department information on biliary atresia treatment | View source |
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| ID | Term |
|---|---|
| D001656 | Biliary Atresia |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
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| ID | Term |
|---|---|
| D011171 | Portoenterostomy, Hepatic |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
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| 21475026 | Derived | 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. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |