Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT

Study Overview
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Brief Summary
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Arterial flushing is a standard recommendation in deceased donor liver transplantation but not in living donor liver transplantation due to the risk of arterial intimal injury and short cold ischaemia time. There is recent evidence on benefit of retrograde arterial perfusion using hepatic venous occlusion and its benefits on post transplant cholestasis. However there is no data on antegrade arterial flushing.

Detailed Description
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Biliary reconstruction has been labeled the Achilles heel of liver transplantation and is a common cause of postoperative morbidity and also mortality .Living donor liver transplantation (LDLT) has a higher incidence of biliary complications of up to 30% which is higher than Deceased Donor Liver Transplantation and does not seem to improve significantly with experience.The virtually unchanged incidence of biliary strictures suggests that they are not simply technical in origin, but probably represent a mucosa ischemic injury inherent in the transplantation procedure. The blood supply of the bile duct is mainly from the arterial system and skeletonisation of the duct during dissection impairs the blood supply rendering it ischemic. Various donor maneuvers for better flushing and preserving peribiliary vascular plexus and biliary mucosa have been studied to decrease biliary complications. LDLT have advantages of haemodynamic stable donor and short cold ischemia but also has disadvantages of small graft size, small ducts, complicated reconstruction and absence of arterial flush. Conventional portal flush in animal livers could not remove warm blood from the arterial system and grafts without retrograde arterial flush had higher post operative bilirubin.With further studies in Living Donor Liver Transplant, it was concluded that retrograde flushing may ameliorate post operative cholestasis. There has not been data published on antegrade arterial flushing and its effect on biliary complications in Living Donor Liver Transplant. This study aims to compare back table graft arterial and portal flushing with portal flushing alone and evaluate biliary and arterial complications. Arterial flushing has been made part of standard protocol at our institute and its safety established. There are centers which routinely perform back table arterial flush.

Official Title
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Antegrade Arterial and Portal Flushing Versus Portal Flushing Only of the Liver Graft in Living Donor Liver Transplantation and Its Effects on Biliary Complications and Graft Function: A Randomized Control Study

Conditions
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Biliary Complications, Graft Function, Delayed

Intervention / Treatment
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* Procedure: Arterial Flushing
* Procedure: Portal Flushing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing living donor liver transplant for decompensated chronic liver disease with right lobe grafts only Exclusion Criteria: Donor artery size less than 2 mm More than one donor artery GRWR <0.8 ABO incompatible grafts Refusal to participate in the study Emergency transplants
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
Interventional Model Description: Subsequent patients undergoing living donor liver transplant with right lobe grafts will be randomised
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arterial and Portal Flushing of Graft<br>Back table flush of portal vein and graft artery | Procedure: Arterial Flushing<br> <br> Procedure: Portal Flushing<br> <br> |
| Active Comparator: Portal Flushing only of Graft<br>Back table flush of portal vein only | Procedure: Portal Flushing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on biliary complications | Occurence of biliary complication | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Occurrence of complications | 1 month | 
| Morbidity |  | 1 month | 
| Effect on graft function |  | 3 months |