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NCT Number: NCT04654728

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

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].

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipol University Faculty of Medicine

Istanbul, 34214, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Active Comparator: ePTFE graft

Procedure

In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts

Other names: Other: Dacron graft

Primary outcomes

  1. Graft patency at 6-month posttransplant

    Time frame: 6 months

    Graft Patency

Secondary outcomes

  1. Graft-related complications

    Time frame: One Year

    Rate of graft infection

  2. Graft survival

    Time frame: One year

    Morbidity

  3. Patient survival

    Time frame: One Year

    Mortality

  4. Graft regeneration rate

    Time frame: 6 months

    Graft regeneration

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Prospective Randomized Study Comparing ePTFE Versus Dacron Graft Donor Liver Transplantation

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2020
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.