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临床试验/NCT04654728
NCT04654728已完成不适用

Prospective Randomized Study Comparing ePTFE Versus Dacron Graft Donor Liver Transplantation

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Graft patency at 6-month posttransplant

研究概览

简要总结

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].

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

None(Open Label)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •Right Lobe graft without anterior sector venous outflow reconstruction
  • •Liver re-transplantation -

研究组 & 干预措施

ePTFE graft

Active Comparator

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

干预措施: 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

干预措施: Active Comparator: ePTFE graft (Procedure)

结局指标

主要结局

Graft patency at 6-month posttransplant

时间窗: 6 months

Graft Patency

次要结局

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

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ATIF TEKIN

General Surgery Residence

Istanbul Medipol University Hospital

研究点 (1)

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