Duct-to-duct vs Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.

Detailed Description
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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.

Official Title
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Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

Conditions
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Liver Transplantation

Intervention / Treatment
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* Procedure: surgical technique: duct-to-duct biliary reconstruction
* Procedure: surgical technique: roux-en-y biliary reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with end-stage liver disease living donor liver transplantation using right hemi-liver as graft duct anastomosis possible at time of surgery donor and recipient aged 18 yrs or older written informed consent obtained Exclusion Criteria: duct anastomosis not possible acute fulminant liver failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Procedure: surgical technique: duct-to-duct biliary reconstruction<br>* surgical reconstruction<br>|
| Other: 2<br> | Procedure: surgical technique: roux-en-y biliary reconstruction<br>* surgical reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary complications defined as leaks and strictures within the first year post LDLT; |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft and patient survival |  | 1 year post-transplant | 
| Length of hospital-stay and ICU-stay |  | within first 30 days after discharge | 
| Any infection or rejection episodes |  | 1 year post- transplant | 
| time to full oral nutrition |  | within 30 days of discharge |