A Single-center Randomized Controlled Study of Secondary Prophylaxis of Cirrhosis Related Esophagogastric Variceal Hemorrhage Treated With HVPG-guided Therapy or Standard Esophageal Variceal Ligation Plus Beta-blocker
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Variceal rebleeding rate
研究概览
简要总结
A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of esophageal variceal hemorrhage.Primary study outcome of the study is variceal rebleeding episodes occurring within the first years after interventions. Second study outcomes of the study are hepatic encephalopathy occurrence, mortality occurrence, liver transplantation or other cirrhosis-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Liver cirrhosis diagnosed by clinical examination, imaging or biopsy;
- •A previous history of variceal hemorrhage;
- •Written informed consent.
排除标准
- •Previous history of secondary prophylactic treatment;
- •Contraindications to treatment of endoscopy, surgery and TIPS
- •Severe cardiac, pulmonary or renal dysfunction;
- •Lactating or pregnant;
- •Malignancies;
研究组 & 干预措施
HVPG group
HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG)
干预措施: HVPG-guided therapy (Procedure)
Routing group
Routing therapy (EVL plus NSBB)
干预措施: Routing Therapy (Procedure)
结局指标
主要结局
Variceal rebleeding rate
时间窗: One year of follow-up
The incidence of clinically significant gastrointestinal variceal bleeding
次要结局
- Liver transplant-free survivial(One year of follow-up)
- Hepatic encephalopathy: The incidence of hepatic encephalopathy(One year of follow-up)
- Cirrhotic complications(One year of follow-up)
- Ascites: The incidence of ascites detected by ultrasound(One year of follow-up)
研究者
Li Yang
Director of Department of Gastroenterology and Hepatology
West China Hospital