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

NCT ID: NCT04654728

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2022-12-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ePTFE graft

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

Group Type: ACTIVE_COMPARATOR

Active Comparator: ePTFE graft

Intervention Type: PROCEDURE

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

Dacron graft

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

Group Type: OTHER

Active Comparator: ePTFE graft

Intervention Type: PROCEDURE

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

Interventions

Active Comparator: ePTFE graft

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

Intervention Type: PROCEDURE

Other Intervention Names

Other: Dacron graft

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

ATIF TEKIN

General Surgery Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murat Dayangac, M.D.

Role: STUDY_DIRECTOR

Study Chief

Locations

Medipol University Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Medipol Transplant

Identifier Type: -

Identifier Source: org_study_id