Prospective Randomized Study Comparing ePTFE Versus Dacron Graft for Anterior Sector Venous Drainage in Right Lobe Living Donor Liver Transplantation

Study Overview
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Brief Summary
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Living donor liver transplantation (LDLT) using the right lobe (RL) has created a significant increase in graft supply worldwide. However, it is a technically demanding procedure particularly because of the unique functional anatomic characteristics of hepatic venous drainage [1].

Detailed Description
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In the absence of an adequate drainage of the anterior sector (AS) veins, the consequent venous congestion in the RL graft may result in impaired graft regeneration, immediate liver dysfunction, and graft loss even in a liver graft of adequate size [2]. To overcome this problem, Lee et al. [3] introduced the concept of modified RL graft in which the branches of the middle hepatic vein (MHV) was drained using interposition vascular grafts. Although, the issue of when and how the MHV branches should be drained has been controversial since then, reconstruction of segment 5 and 8 veins using an interposition graft has become a standard procedure during RL LDLT. The vascular graft of choice in this procedure has been cryopreserved homologous vein graft, which provides excellent patency with low infection risk. However, such grafts are often unavailable, particularly in programs where deceased donors are scarce and surgeons must rely on synthetic grafts such as expanded polytetrafluoroethylene (ePTFE) and polyethylene terephthalate (Dacron®). Since we have developed an intent-to-drain policy in our LDLT program, we have been using Dacron grafts exclusively [4]. Although, complications such as early graft thrombosis, graft infection, and hollow viscous migration remain as major concerns, the safety and efficacy of both ePTFE and Dacron grafts in LDLT has been proven [5, 6]. However, to date, none of the previous studies have specifically compared these two different prosthetic materials, addressing graft patency and complication rates in patients undergoing LDLT. The aim of our study is to compare AS venous outflow reconstruction using ePTFE vs. Dacron grafts for their patency and infection rates and outcomes with respect to graft and patient survival in RL LDLT.

Official Title
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Prospective Randomized Study Comparing ePTFE Versus Dacron Graft Donor Liver Transplantation

Conditions
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Patency and Infection Rates Due to Usage of PTFE vs.Dacron Grafts

Intervention / Treatment
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* Procedure: Active Comparator: ePTFE graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Adult Living Donor Liver Transplantation Right Lobe graft with anterior sector venous outflow reconstruction - Exclusion Criteria: Right Lobe graft without anterior sector venous outflow reconstruction Liver re-transplantation -

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: Patients will be equally randomized into two groups using sealed envelope system. For anterior sector venous drainage, ePTFE vascular grafts (straight or bifurcated) in group 1, and Dacron grafts(straight or bifurcated) in 2 will be used as conduit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ePTFE graft<br>In this group, anterior sector of the right lobe graft will be reconstructed using ePTFE vascular grafts | Procedure: Active Comparator: ePTFE graft<br>* In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts<br>* Other names: Other: Dacron graft;|
| Other: Dacron graft<br>In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts | Procedure: Active Comparator: ePTFE graft<br>* In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts<br>* Other names: Other: Dacron graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft patency at 6-month posttransplant | Graft Patency | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft-related complications | Rate of graft infection | One Year | 
| Graft survival | Morbidity | One year | 
| Patient survival | Mortality | One Year | 
| Graft regeneration rate | Graft regeneration | 6 months |