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

Not Applicable

Completed

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

• Registration Number: NCT04654728
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Study First Submitted: 2020-11-23
• Study Start: 2020-12-02
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Primary Completion: 2022-09-24
• Study Completion: 2022-12-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Graft patency at 6-month posttransplant	6 months	Graft Patency

Secondary Outcome Measures

Name	Time	Method
Graft survival	One year	Morbidity
Graft-related complications	One Year	Rate of graft infection
Patient survival	One Year	Mortality
Graft regeneration rate	6 months	Graft regeneration

Trial Locations

Locations (1)

Medipol University Faculty of Medicine; 🇹🇷 Istanbul, Turkey