Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of Portal vein pressure
研究概览
简要总结
In this study, investigators aim to screen out the patients with portal hypertension by monitoring intraoperative PVP, and to decide the effect of Terlipressinum on the portal pressure after liver resection.
详细描述
Liver resection is a common treatment for liver tumors. But the incidence of postoperative liver failure after hepatectomy is as high as 9-18.6%, which results in relatively high mortality rate . Portal hypertension is considered as a contraindication for hepatectomy according to the guidelines of the European Society of Hepatology and the American Society of Hepatology. Recent studies found that patients with portal hypertension were more likely to have persistent liver failure and shorter long-term survival after liver resection operation, compared to patients without portal hypertension.
Most of liver cancer patients in China have disease backgroud including chronic hepatitis and cirrhosis. Among liver cancer patients, of which function is Child A or B and have indication for liver resection, 25% of them have portal hypertension.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receives liver resection.
- •PVP is more than 12mmHg in 5 minutes after liver resection.
排除标准
- •Age: <18, >75;
- •Portal vein tumor thrombus is confirmed by preoperative assays;
- •Obstruction of biliary tract;
- •Active hepatitis;
- •Previous history of myocardial infarction;
- •Previous history of chronic kidney disease;
- •Severe arrhythmia;
- •Any other contraindications of the Terlipressinum.
研究组 & 干预措施
Terlipressinum
If the PVP is over 12 mmHg after hepatectomy, 1mg of Terlipressinum was given to patients intravenously. If the portal vein pressure is decreased by 1 mmHg, then 2mg of Terlipressinum was continuously given every day in the next 4 days after liver resection.
干预措施: Terlipressinum (Drug)
结局指标
主要结局
Change of Portal vein pressure
时间窗: 8 months
The change of the portal vein pressure before and after the use of Terlipressinum.
次要结局
- Incidence of hepatic dysfunction after hepatectomy(8 months)
- Incidence of acute renal dysfunction after hepatectomy(8 months)
- Adverse effect of Terlipressurinum(8 months)