Duct-to-duct vs Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT00646685|
Recruitment Status : Unknown
Verified June 2012 by University Health Network, Toronto.
Recruitment status was: Enrolling by invitation
First Posted : March 28, 2008
Last Update Posted : July 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation||Procedure: surgical technique: duct-to-duct biliary reconstruction Procedure: surgical technique: roux-en-y biliary reconstruction||Phase 4|
The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.
Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2016|
Procedure: surgical technique: duct-to-duct biliary reconstruction
Procedure: surgical technique: roux-en-y biliary reconstruction
- Biliary complications defined as leaks and strictures within the first year post LDLT; [ Time Frame: 1 year ]
- Graft and patient survival [ Time Frame: 1 year post-transplant ]
- Length of hospital-stay and ICU-stay [ Time Frame: within first 30 days after discharge ]
- Any infection or rejection episodes [ Time Frame: 1 year post- transplant ]
- time to full oral nutrition [ Time Frame: within 30 days of discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646685
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Markus Selzner, MD||University Health Network, Toronto|