The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- in hospital mortality
研究概览
简要总结
Post hepatectomy liver failure (PHLF) is a serious medical problem could lead to patient death, however, definite treatment strategy has not been established. The liver is a regenerating organ and the possibility of PHLF could be reduced when the appropriate liver regeneration is guaranteed.
Portal flow has known to be important during liver regeneration. Low portal flow cannot induce proper regeneration, contrary, excessive flow increase shear stress in the hepatic sinusoid resulting liver failure.
Various medications has been used in malignant liver cirrhosis to reduce portal pressure. Among them, somatostatin has been used modulating portal flow reducing portal and sinusoidal pressure.
In this study, the investigators administrate somatostatin at a rate of 3.5ug/kg/hour to PHLF patients (prothrombin time < 50% and serum total bilirubin > 2.9mg/dl after liver resection) until recovery from liver failure. For assessment of the recovery of liver failure, the investigators evaluate aspartate transaminase (AST), alanine transaminase (ALT), serum total bilirubin and prothrombin time periodically after administration of medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PHLF without regard primary disease.
- •Ability to provide written informed consent
排除标准
- •Concomitant surgery for another intraabdominal organs.
- •Severe renal disease requiring dialysis.
- •Patients with coagulation disorders or taking warfarin.
- •Immunosuppressed patients or the patients with autoimmune disorders.
- •Women with pregnant, breast-feeding.
- •Hypersensitivity to somatostatin.
- •Patients treated with other investigational product within 30 days at the consents are obtained.
- •Patients with a significantly reduced cognitive abilities.
- •Not eligible to participate for study at the discretion of investigator.
研究组 & 干预措施
somatostatin group
The investigators administrate somatostatin at a rate of 3.5ug/kg/hour to PHLF patients (prothrombin time < 50% and serum total bilirubin > 2.9mg/dl after liver resection) until recovery from liver failure.
干预措施: Somatostatin (Drug)
结局指标
主要结局
in hospital mortality
时间窗: up to 4 weeks
次要结局
- Time to recovery from PHLF (days)(up to 4 weeks)
- Complication rate(up to 4 weeks)
研究者
Jae Hyun Han
clinical assistant professor
Korea University Anam Hospital