Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis：A Zelen-design Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Recanalization rate of PVT
研究概览
简要总结
The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.
详细描述
The treatment of cirrhotic patients with PVT (portal vein thrombosis) is clearly recommended in guideline now. Several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with PVT.The present studies are most observation studies with small sample size and low quality. The investigators need more high-quality research such as randomized controlled trials. This is a Zelen-designed multicenter randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator will make sure wether their are fond of the group and make decision by themselves. The recanalization rate and complications will be analyzed
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years old;
- •A clinical, radiological or histologic diagnosis of Liver cirrhosis and portal hypertension;
- •Diagnosed of Portal vein thrombosis;
- •Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
- •Have undergone endoscopy to prevent variceal rebleeding.
排除标准
- •Age <18 or >70 years;
- •Portal vein thrombosis diagnosed before 6 months;
- •Patients with signs of acute PVT such as fever，abdominal pain or intestinal obstruction，who should be treated immediately;
- •Pregnant or nursing;
- •Hepatocellular carcinoma or other cancer;
- •Severe cardiopulmonary diseases or concomitant renal insufficiency;
- •cavernous transformation of the portal vein;
- •Contradictions to endoscopy;
- •Contradictions to anticoagulation,such as:allergy to LMWH or warfarin, severe uncontrolled hypertension, history of hemorrhagic cerebral vascular accident, recent peptic ulcer disease, bacterial endocarditis, ulcerative colitis，sustained platelet count < 50 x10^9/L);
- •Taking immunosuppressive agent;
- •Coagulation disorders other than the liver disease related;
- •Variceal bleeding failed to control.
研究组 & 干预措施
Control.
No anticoagulation，just routine follow up.
干预措施: Doppler ultrasound and CT (Device)
Anticoagulation
Nadroparin Calcium and Warfarin
干预措施: Nadroparin Calcium and Warfarin (Drug)
Anticoagulation
Nadroparin Calcium and Warfarin
干预措施: Doppler ultrasound and CT (Device)
结局指标
主要结局
Recanalization rate of PVT
时间窗: through study completion，an average of 18 months
Patients will receive Doppler ultrasound and CT before enrolled and followed up by Doppler ultrasound every 3 months ,by CT every 6 months after enrolled，untill the end of the study.
次要结局
- Rebleeding rate(through study completion，an average of 18 months)
- Incidence rate of complications(through study completion，an average of 18 months)
研究者
Shiyao Chen
Director of department of Gastroenterology, Zhongshan Hospital
Shanghai Zhongshan Hospital