Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation

Study Overview
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Brief Summary
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Comparison of biliary complications in right lobe living donor liver transplantation patients undergoing biliary reconstructions using microscope versus surgical loupes .

Detailed Description
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Liver transplantation (LT) is the most effective treatment modality in patients with end-stage liver disease and it is also established as a viable treatment option in the field of oncology. Living donor liver transplantation (LDLT) using the right lobe (RL) is a major achievement despite its technical challenges, which has created a significant increase in graft supply. While a secure bile duct anastomosis is one of the basic principles of a successful liver transplant procedure, biliary reconstruction remains the Achilles' heel of LDLT because of the high incidence of posttransplant biliary complications associated with significant recipient morbidity and mortality. Some of these complications are related to technical difficulties due to multiple small biliary orifices, particularly in right lobe grafts. In our center, we have been using microsurgical reconstruction technique for duct-to-duct biliary anastomosis in such grafts. The routine use of this technique has been shown to significantly decrease biliary complications in single-center retrospective studies. However, prospective controlled studies comparing microsurgical and standard biliary reconstruction techniques are lacking. In this study, our objective is to compare posttransplant complications of the two techniques of biliary reconstruction in RL LDLT. 40 patients will be included in the study. They will be randomly allocated in the equal groups.İn group 1 biliary anastomosis will be performed using surgical loupes and İn group 2 biliary anastomosis will be performed using microscope. The patients will be followed for one year after the transplant to compare biliary complications.

Official Title
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Prospective Randomized Single-center Trial Comparing Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation

Conditions
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Liver Failure, Liver Diseases, Liver Cancer, Liver Neoplasms, Liver Dysfunction

Intervention / Treatment
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* Other: Surgical Loupes
* Other: Microscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Primary Adult Living donor liver transplant 2.Right lobe grafts with a single biliary orifice Exclusion Criteria: 1.Bile duct diameter < 3mm 2.Biliary costructions with a hepaticojejunostomy 3.Right lobe grafts with multipl biliary orifice

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: The patients will be randomly allocated in the equal groups.İn group 1 biliary anastomosis will be performed using surgical loupes and İn group 2 biliary anastomosis will be performed using microscope.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical Loupes<br>In this group , patients will undergo biliary reconstruction using surgical loupe | Other: Surgical Loupes<br>* Biliary reconstruction will be performed using surgical loupe<br>|
| Active Comparator: Microscope<br>In this group , patients will undergo biliary reconstruction using microscope | Other: Microscope<br>* Biliary reconstruction will be performed using microscope<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 morbidity | Morbidity | One year | 
| Perioperative mortality | Mortality | Through study completion, an average of 1 year | 
| Time to biliary complications | Time to biliary complications | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transplantation, Living donor liver transplantation, Biliary anastomosis