Remote Ischemia Precondition for Hepatic Protection in Patients Undergoing Hepatectomy: A Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- survival rate
研究概览
简要总结
Remote ischemia precondition could protect the liver from ischemia reperfusion injury in patients undergoing hepatectomy.
详细描述
Remote ischemia precondition (RIPC) had been proofed beneficial to ischemia reperfusion injury of heart, kidney, liver, brain and spinal cord in experimentation on animals. And the clinical studies of RIPC were mainly focused on heart, RIPC's protection effect on hepatic ischemia reperfusion injury in patients undergoing hepatectomy still remains unknown, So we designed this study to demonstrate the hypotheses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No other main organ diseases, American society of Anesthesiologists (ASA) classification Ⅰ-Ⅱ grade
- •Selective hepatectomy, one time hepatic portal occlusion
- •Child-Pugh A
排除标准
- •Peripheral vessels diseases
- •Not the same surgical procedure as expected
- •Administered anti-inflammatory drugs as glucocorticoid etc
- •Diagnosed of diabetes
- •History of liver surgery
- •History of hepatic interventional therapy, radiofrequency therapy,radiotherapy and chemotherapy
- •Refuse to join the research
- •Patients with psychopathy
- •Acute infection need antibiotic therapy
- •Hepatic artery or portal vein embolism
研究组 & 干预措施
Remote ischemia precondition
patients in this arm accepted RIPC procedure after induction of anesthesia
干预措施: Remote ischemia precondition (Other)
None remote ischemia precondition
patients in this arm didn't accept RIPC procedure after induction of anesthesia
干预措施: None remote ischemia precondition (Other)
结局指标
主要结局
survival rate
时间窗: 30 days postoperatively
次要结局
- alanine aminotransferase (ALT) level in patients' blood(7 days postoperatively)
- aspartic transaminase (AST) level in patients' blood(7 days postoperatively)
- complications(30 days postoperatively)
- alanine aminotransferase (ALT) level in patients' blood(1 day postoperatively)
- aspartic transaminase (AST) level in patients' blood(1 day postoperatively)
- alanine aminotransferase (ALT) level in patients' blood(3 days postoperatively)
- aspartic transaminase (AST) level in patients' blood(3 days postoperatively)
研究者
Wei-feng Yu
professor
Eastern Hepatobiliary Surgery Hospital