跳至主要内容
临床试验/CTRI/2018/11/016315
CTRI/2018/11/016315招募中不适用

Randomized Controlled Trial to compare Early Postoperative Outcomes of Polytetrafluoroethylene Graft Vs. Native Recipient Portal Vein fro Middle Hepatic Vein Reconstruction in the Recipient following Live Donor Liver Transplantation

Amrita Institute of Medical Sciences Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月8日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
GRAFT PATENCY RATE assessed by DUPLEX ULTRASONOGRAM and confirmed with cross sectional imaging either CT or MRI in the event of thrombosis detected by Duplex

研究概览

简要总结

This is a prospective randomized control trial in adult living donor liver transplant where right lobe graft is used. The anterior sectoral venous outflow is reconstructed to form the neo-middle hepatic vein (MHV). The reconstruction of the MHV can either be with the Portal Vein (PV) from the recipient explanted liver, allogenous veins or synthetic grafts. This trial iis to compare the outcomes of PTFE graft vs PV for the neo-MHV reconstruction in term of neo- MHV patency, early graft dysfunction, 90-day mortality and other parameters.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ADULT to ADULT LIVE DONOR LIVER TRANSPLANT PATIENTS with Decompensated Liver Disease (Acute/Subacute/Chronic) Live Donor suitable for Right lobe donation with
  • Functional Liver Reserve > 30%
  • Adequate Segment 4 drainage to the Left Hepatic Vein
  • Steatosis < 20% assesses by Plain CT.

排除标准

  • PORTAL VEIN THROMBOSIS IN THE RECIPIENT HEPATOCELLULAR CARCINOMA IN THE RECIPIENT ABO Incompatible Transplants DONOR.
  • TYPE II or TYPE III Portal vein anatomy.

结局指标

主要结局

GRAFT PATENCY RATE assessed by DUPLEX ULTRASONOGRAM and confirmed with cross sectional imaging either CT or MRI in the event of thrombosis detected by Duplex

时间窗: First two weeks (daily doppler in the first week and alternate day doppler in the second week) | at weekly intervals till 90 days

次要结局

  • GRAFT FUNCTION :(EARLY ALLOGRAFT DYSFUNCTION)
  • MORBIDITY :(Complications :)
  • ICU Stay(Hospital Stay)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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