The Effect of Remote Ischemic Preconditioning on the Postoperative Liver Function in Living Donor Hepatectomy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days
研究概览
简要总结
Liver transplantation is the gold standard treatment for patients with end-stage liver disease. Despite its outstanding success, liver transplantation still entails certain complications including ischemia-reperfusion injury. Remote ischemic preconditioning is a novel and simple therapeutic method to lessen the harmful effects of ischemia-reperfusion injury, however, the majority of remote ischemic preconditioning studies on hepatic ischemia-reperfusion injury have been animal studies. Therefore, our aim was to assess the effects of remote ischemic preconditioning on postoperative liver function in living donor hepatectomy.
详细描述
Liver transplantation(LT) is the gold standard treatment for patients with end-stage liver disease. In light of advancements in surgical techniques, immunosuppressive agents, and perioperative critical care, the overall 3-year survival of patients undergoing LT has exceeded 80%. Despite its outstanding success, LT still entails certain complications including ischemia-reperfusion injury (IRI).
IRI occurs when the blood supply to an organ or tissue is temporarily cut-off and then restored, and it is well-known as an underlying cause of primary non-function, biliary complications, and eventual graft loss after LT. Despite many attempts to ameliorate hepatic IRI, no definitive therapies have been established. In addition, the mechanisms of IRI remain largely unclear.
Remote ischemic preconditioning (RIPC) is a novel and simple therapeutic method to lessen the harmful effects of IRI. RIPC indicate that brief episodes of ischemia with intermittent reperfusion are introduced at a remote site, leading to systemic protection against subsequent insults as evinced on kidney, heart, liver, and other tissues. While RIPC has been shown to reduce hepatic IRI in several small animal studies, the beneficial effects of RIPC in hepatic IRI have been inconsistent. By far, the majority of RIPC studies on hepatic IRI have been animal studies; hence, there are limitations relating to the lack of human clinical trials.
Therefore, our aim was to assess the effects of RIPC on postoperative liver function in living donor hepatectomy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donors who plan to have living right hepatectomy for liver transplantation.
- •age : between 18 to 60 years.
排除标准
- •donors who plan to donate left lobe
- •donors who plan to have laparoscopic right hepatectomy
- •donors who cannot proceed remote ischemic preconditioning
研究组 & 干预措施
RIPC
intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started.
干预措施: remote ischemic preconditioning (Procedure)
Control
In the control group, the same maneuver was applied but without cuff inflation.
结局指标
主要结局
Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days
时间窗: within 7 days after operation
The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal aspartate aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy.
The Maximal Alanine Aminotransferase Level Within 7 Postoperative Days
时间窗: within 7 days after operation
The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal alanine aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy
次要结局
- Number of Participants With Delayed Recovery of Liver Function(postoperative 7 days)
- Postoperative Liver Regeneration(1 month)
研究者
Jun-Gol Song
Associate Professor
Asan Medical Center