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This study was designed to demonstrate incidence of biliary complication rates after living donor liver transplantation according to the implantation of external biliary drainage throug duct-to-duct anastomosis site.
Biliary complication is the most common complications after liver transplantation, and it happens more often after living donor liver transplantation (LDLT) than deceased donor liver transplantation.
Many transplant centers adopted their own methods to improve biliary complications after LDLT. One suggested method is the application of external biliary drainage (EBD).
A prospective study was planned to demonstrate effect of EBD on biliary complication after LDLT. Patients who underwent LDLT with duct-to-duct anastomosis will be randomly assinged to application of EBD or conventional duct-to-duct anastomosis without EBD according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two groups.
Primary outcome is biliary complication incidence 1 year after LDLT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Application of external biliary drainage |
|
| Control group | No Intervention | Conventional duct-to-duct anastomosis (with or without internal stent) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External biliary drainage | Procedure | Application of external biliary drainage through duct-to-duct anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biliary complication within 1 year after LDLT | Biliary stricture/leakage | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biliary complication within 3 year after LDLT | Biliary stricture/leakage | 3 year |
| Complication associated with external biliary drainage | Dislocation, retraction, reposition, leakage through tube site, hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su young Hong, MD | Contact | +82-2-2072-2326 | sypurple@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Suk Kyun Hong, MD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18976306 | Background | Freise CE, Gillespie BW, Koffron AJ, Lok AS, Pruett TL, Emond JC, Fair JH, Fisher RA, Olthoff KM, Trotter JF, Ghobrial RM, Everhart JE; A2ALL Study Group. Recipient morbidity after living and deceased donor liver transplantation: findings from the A2ALL Retrospective Cohort Study. Am J Transplant. 2008 Dec;8(12):2569-79. doi: 10.1111/j.1600-6143.2008.02440.x. Epub 2008 Oct 24. | |
| 21143651 |
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| 3 year |
| Graft survival | Survival of liver graft | 3 year |
| Patient survival | Patient survival after LDLT | 3 year |
| Patient-reported outcome | Questionnaire survey | 3 year |
| Background |
| Akamatsu N, Sugawara Y, Hashimoto D. Biliary reconstruction, its complications and management of biliary complications after adult liver transplantation: a systematic review of the incidence, risk factors and outcome. Transpl Int. 2011 Apr;24(4):379-92. doi: 10.1111/j.1432-2277.2010.01202.x. Epub 2010 Dec 10. |
| 16528711 | Background | Hwang S, Lee SG, Sung KB, Park KM, Kim KH, Ahn CS, Lee YJ, Lee SK, Hwang GS, Moon DB, Ha TY, Kim DS, Jung JP, Song GW. Long-term incidence, risk factors, and management of biliary complications after adult living donor liver transplantation. Liver Transpl. 2006 May;12(5):831-8. doi: 10.1002/lt.20693. |
| 32387205 | Background | Jung DH, Ikegami T, Balci D, Bhangui P. Biliary reconstruction and complications in living donor liver transplantation. Int J Surg. 2020 Oct;82S:138-144. doi: 10.1016/j.ijsu.2020.04.069. Epub 2020 May 5. |
| 24767322 | Background | Park CS, Jung BH, Hwang S, Park YH, Kang SH, Park GC, Song GW, Jung DH, Ahn CS, Kim KH, Moon DB, Ha TY, Lee SG. External biliary drainage in living donor liver transplantation using duct-to-duct anastomosis. Transplant Proc. 2014 Apr;46(3):678-81. doi: 10.1016/j.transproceed.2013.11.150. |
| 25358749 | Background | Lee SG. A complete treatment of adult living donor liver transplantation: a review of surgical technique and current challenges to expand indication of patients. Am J Transplant. 2015 Jan;15(1):17-38. doi: 10.1111/ajt.12907. Epub 2014 Oct 30. |