Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Variceal rebleeding rate
研究概览
简要总结
The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
详细描述
For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
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
- •Patients who had bled from esophageal varices (≥5days and ≤28days)
- •Child-Pugh B or Child-Pugh C≤13
排除标准
- •THE presence of gastric varices
- •Non-cirrhotic portal hypertension
- •Portal vein thrombosis
- •The history of hepatic encephalopathy
- •Total bilirubin ≥51.3 umol/L
- •Previous treatment of TIPS or surgery
- •Proven malignancy including hepatocellular carcinoma
- •Contraindications to TIPS、EVL or propranolol
- •End-stage renal disease under renal replacement therapy;
- •Cardiorespiratory failure
- •Pregnancy or patients not giving informed consent for endoscopic procedures
研究组 & 干预措施
8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
干预措施: 8mm-TIPS (Procedure)
8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
干预措施: 8mm ePTFE-covered stent (Device)
EVL plus propranolol
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
干预措施: Endoscopic variceal ligation (Procedure)
EVL plus propranolol
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
干预措施: Propranolol (Drug)
结局指标
主要结局
Variceal rebleeding rate
时间窗: 3 years
Analysis
次要结局
- Number of participants with improving or worsening hepatic function(3 years)
- The incidence of complications(3 years)
- Hepatic encephalopathy rate(3 years)
- Number of participants with improving or worsening quality of life(3 years)
- TIPS dysfunction rate(3 years)
- Mortality rate(3 years)