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临床试验/NCT03048318
NCT03048318已完成4 期

Antegrade Arterial and Portal Flushing Versus Portal Flushing Only of the Liver Graft in Living Donor Liver Transplantation and Its Effects on Biliary Complications and Graft Function: A Randomized Control Study

Institute of Liver and Biliary Sciences, India0 个研究点目标入组 85 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
85
主要终点
Effects on biliary complications

研究概览

简要总结

Arterial flushing is a standard recommendation in deceased donor liver transplantation but not in living donor liver transplantation due to the risk of arterial intimal injury and short cold ischaemia time. There is recent evidence on benefit of retrograde arterial perfusion using hepatic venous occlusion and its benefits on post transplant cholestasis. However there is no data on antegrade arterial flushing.

详细描述

Biliary reconstruction has been labeled the "Achilles heel" of liver transplantation and is a common cause of postoperative morbidity and also mortality .Living donor liver transplantation (LDLT) has a higher incidence of biliary complications of up to 30% which is higher than Deceased Donor Liver Transplantation and does not seem to improve significantly with experience.The virtually unchanged incidence of biliary strictures suggests that they are not simply "technical" in origin, but probably represent a mucosa ischemic injury inherent in the transplantation procedure. The blood supply of the bile duct is mainly from the arterial system and skeletonisation of the duct during dissection impairs the blood supply rendering it ischemic.

Various donor maneuvers for better flushing and preserving peribiliary vascular plexus and biliary mucosa have been studied to decrease biliary complications. LDLT have advantages of haemodynamic stable donor and short cold ischemia but also has disadvantages of small graft size, small ducts, complicated reconstruction and absence of arterial flush. Conventional portal flush in animal livers could not remove warm blood from the arterial system and grafts without retrograde arterial flush had higher post operative bilirubin.With further studies in Living Donor Liver Transplant, it was concluded that retrograde flushing may ameliorate post operative cholestasis. There has not been data published on antegrade arterial flushing and its effect on biliary complications in Living Donor Liver Transplant. This study aims to compare back table graft arterial and portal flushing with portal flushing alone and evaluate biliary and arterial complications.

Arterial flushing has been made part of standard protocol at our institute and its safety established. There are centers which routinely perform back table arterial flush.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients undergoing living donor liver transplant for decompensated chronic liver disease with right lobe grafts only

排除标准

  • Donor artery size less than 2 mm
  • More than one donor artery
  • GRWR <0.8
  • ABO incompatible grafts
  • Refusal to participate in the study
  • Emergency transplants

结局指标

主要结局

Effects on biliary complications

时间窗: Three months

Occurence of biliary complication

次要结局

  • Hospital stay(1 month)
  • Effect on graft function(3 months)
  • Morbidity(1 month)

研究者

申办方类型
Other
责任方
Sponsor

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