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Clinical Trials/NCT04654728
NCT04654728CompletedNot Applicable

Prospective Randomized Study Comparing ePTFE Versus Dacron Graft Donor Liver Transplantation

Istanbul Medipol University Hospital1 site in 1 country60 target enrollmentStarted: December 2, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Graft patency at 6-month posttransplant

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

None(Open Label)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 -

Arms & Interventions

ePTFE graft

Active Comparator

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

Intervention: Active Comparator: ePTFE graft (Procedure)

Dacron graft

Other

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

Intervention: Active Comparator: ePTFE graft (Procedure)

Outcomes

Primary Outcomes

Graft patency at 6-month posttransplant

Time Frame: 6 months

Graft Patency

Secondary Outcomes

  • Graft survival(One year)
  • Graft-related complications(One Year)
  • Patient survival(One Year)
  • Graft regeneration rate(6 months)

Investigators

Sponsor
Istanbul Medipol University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ATIF TEKIN

General Surgery Residence

Istanbul Medipol University Hospital

Study Sites (1)

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