Clinical trial NCT04654728: Prospective Randomized Study Comparing ePTFE Versus Dacron Graft for Anterior Sector Venous Drainage in Right Lobe Living Donor Liver Transplantation
Official title: Prospective Randomized Study Comparing ePTFE Versus Dacron Graft Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patency and Infection Rates Due to Usage of PTFE vs.Dacron Grafts
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Primary Adult Living Donor Liver Transplantation
2. Right Lobe graft with anterior sector venous outflow reconstruction -

Exclusion Criteria:

1. Right Lobe graft without anterior sector venous outflow reconstruction
2. Liver re-transplantation -

Primary outcomes:
measure: Graft patency at 6-month posttransplant
timeFrame: 6 months
Secondary outcomes:
measure: Graft-related complications
timeFrame: One Year
measure: Graft survival
timeFrame: One year
measure: Patient survival
timeFrame: One Year
measure: Graft regeneration rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University Faculty of Medicine
Study officials:
affiliation: Study Chief
name: Murat Dayangac, M.D.
role: STUDY_DIRECTOR
References: