NCT03172273招募中不适用
Early Use of Transjugular Intrahepatic Portosystemic Shunt（TIPS）With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
Air Force Military Medical University, China2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年6月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Transplant-free survival
研究概览
简要总结
This multicenter RCT is designed to investigate if TIPS with covered stents improves transplant-free survival for cirrhotic patients with early stage of refractory ascites compared to LVP+albumin during 1 year follow-up period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of liver cirrhosis
- •Recurrent and refractory ascites
- •Patients with an age between 18 and 65 years old
- •Child-Pugh ≤12
- •Absence of hepatic encephalopathy
- •Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
- •Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study
排除标准
- •With more than 6 paracenteses within the last 3 months
- •patients expected to receive transplants within the next 6 months or on waiting list
- •Usual contra-indication for TIPS: congestive heart failure NYHA>III or medical history of pulmonary hypertension, portal vein thrombosis（>50%）, hepatic polycystosis, intra-hepatic bile ducts dilatation
- •Patient has had previous TIPS placement
- •Severe liver dysfunction by: Prothrombin index < 40% or total bilirubin > 50μmol/l
- •Serum creatinine >133μmol/l
- •Severe hyponatremia <125mmol / L
- •Uncontrolled sepsis
- •Gastrointestinal hemorrhage within 6 weeks of randomization
- •Known allergy to albumin
- •Pregnant or breast feeding women
- •Refusal to participate or patient unable to receive informations or to sign written informed consent
结局指标
主要结局
Transplant-free survival
时间窗: 12 months
次要结局
- Frequency of paracentesis(12 months)
- Quality of life(12 months)
- Frequency of overt Hepatic Encephalopathy(12 months)
- Nutritional status(12 months)
- Other Liver Disease Complications (Adverse Events)(12 months)
研究者
Guohong Han
PhD&MD
Xi'an International Medical Center Hospital
研究点 (2)
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