Stented Biliary Anastomosis in Living Donor Liver Transplantation

Study Overview
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Brief Summary
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Determination of biliary complications in stented group compared to duct to duct anastomosis without stent

Detailed Description
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30 patients included in the study. patients will be randomly allocated in two equal groups. In group A anastomosis will be done on intraductal stent and in group B anastomosis done without stent .the patients will be followed for one year to compare the result of two groups as regard biliary complications.

Official Title
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Randomized Controlled Clinical Trial Of Stented Versus Stentless Biliary Anastomosis In Living Donor Liver Transplantation

Conditions
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Liver Transplant

Intervention / Treatment
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* Procedure: living donor liver transplantation with internal biliary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients eligible for a liver transplantation patients' written informed consent signed. Exclusion Criteria: biliary reconstruction requires a hepatico-jejunostomy for anatomical/biliary disease reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intraductal stent<br>in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis with internal biliary stent | Procedure: living donor liver transplantation with internal biliary stent<br>* living donor liver transplantation without internal biliary stent<br>|
| Active Comparator: stentless<br>in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis will done without internal biliary | Procedure: living donor liver transplantation with internal biliary stent<br>* living donor liver transplantation without internal biliary stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biliary complications after living donor liver transplantation | incidence of biliary complications after living donor liver transplantation | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biliary complications | types of biliary complications | one year | 
| biliary related mortality | mortality | one year | 
| rate of cholangitis | rate of cholangitis | 3 months | 
| hospital stay | hospital stay | one month | 
| time 2 biliary complications | time 2 biliary complications | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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living donor liver transplantation, intraductal stent, biliary complications after liver transplantation