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临床试验/NCT03130920
NCT03130920已完成不适用

Comparison of Hepatoprotective Effect From Ischemia-reperfusion Injury of Remote Ischemic Preconditioning of the Liver vs. Local Ischemic Preconditioning of the Liver During Human Liver Resections

University Hospital Dubrava2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月20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
2
主要终点
Change in synthetic liver function

研究概览

简要总结

The aim of this study is to evaluate hepatoprotective effect from ischemia-reperfusion injury of remote ischemic preconditioning of the liver against local ischemic preconditioning of the liver during human liver resections.

详细描述

In this randomized control study, a total of 60 patients were randomized into 3 groups: remote ischemic precondition group - RIPC (3 intervals of 5 minute right upper limb ischemia with 3 intervals of 5 minute reperfusion), local ischemic precondition group - LIPC (15 minutes of inflow liver occlusion followed by 10 minutes of reperfusion before liver transection), control group - CG (group without ischemic preconditioning before liver transection). Patients were also stratified according to the extent of the hepatectomy. Hepatoprotective effect was evaluated by comparing serum transaminase levels, bilirubin levels, albumin, and protein levels, coagulograms and pathohistological exams. We also measured flow rate by Doppler ultrasound of hepatic artery and portal vein before and after preconditioning.

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

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with colorectal cancer liver metastasis all of which signed an informed consent

排除标准

  • having any other underlying liver disease, or preoperative increased liver transaminase, bilirubin
  • patients with chronic cardiac, pulmonary or renal disease

研究组 & 干预措施

Remote ischemic preconditioning

Active Comparator

干预措施: Preconditioning (Procedure)

Local ischemic preconditioning

Active Comparator

干预措施: Preconditioning (Procedure)

Control

No Intervention

结局指标

主要结局

Change in synthetic liver function

时间窗: Preoperatively, first, third and seventh postoperative day

We measured residual synthetic liver function and liver ischemic-reperfusion injury by value level of bilirubin, total proteins, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutamic aminotransferase (ƴGT), cholinesterase, alkaline phosphatase (AP), coagulogram.

次要结局

  • Flow through the hepatic artery and portal vein(Before and after preconditioning)
  • Liver histology evaluation(Up to 10 days after operation)

研究者

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

Mislav Rakić, MD

Head of hepatobilliary Department of surgery

University Hospital Dubrava

研究点 (2)

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