Study on the Effect of Terlipressin on Recovery of Liver Function After Hepatectomy: a Multicenter Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- The total abdominal drainage
研究概览
简要总结
Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. In this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension.
详细描述
Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. In this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension. The primary outcome is the total abdominal drain on postoperative day (POD) 1 to 3. The secondary outcomes are: (1) the incidence of post-hepatectomy liver failure; (2) post-operative acute kidney injury; (3) the side effects of terlipressin.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects signed informed consent.
- •An open liver resection is planned.
- •Hepatitis B virus infection background.
- •Pre-operative liver function is Child-Pugh A.
- •Subjects with clinical significance portal vein hypertension or the liver stiffness > 12 kPa before surgery.
- •Portal vein pressure > 12 mmHg at 5 min after liver resection.
排除标准
- •Age < 18 y or > 75 y.
- •Subjects received anti-cancer therapy within 3 months before surgery, or with a history of open or laparoscopic surgery.
- •Portal vein tumor thrombus was confirmed by preoperative imaging study.
- •Obstruction of biliary tract.
- •Pre-operative ALT or AST > 2×ULN.
- •A history of myocardial infarction or chronic kidney disease.
- •Severe arrhythmia.
- •Intraoperative portal vein pressure could not be measured technically.
- •Any other contraindications of the terlipressin.
研究组 & 干预措施
Terlipressin plus standard care
Immediately after hepatectomy, 1 mg terlipressin was given intravenously after hemostasis was achieved. After surgery, participants were routinely managed, and terlipressin were administrated at a dosage of 2 mg per day for 4 days.
干预措施: Terlipressin plus standard care (Drug)
Standard care
Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.
干预措施: Standard care (Other)
结局指标
主要结局
The total abdominal drainage
时间窗: From post-operative day 1 to day 4.
from postoperative day 1 through day 3.
次要结局
- The incidence of acute kidney injury(From post-operative day 1 to day 30.)
- The incidence of post-hepatectomy liver failure(From post-operative day 1 to day 30.)
- The side effects of terlipressin(From post-operative day 1 to day 30.)