TIPS (With Coated Stents) OR PARACENTESIS + ALBUMIN ADMINISTRATION FOR THE TREATMENT OF REFRACTORY ASCITES IN PATIENTS WITH CIRRHOSIS : A RANDOMIZED TRIAL COMPARING SURVIVAL, QUALITY OF LIFE AND NUTRITIONAL STATUS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 7
- 主要终点
- Survival at one year
研究概览
简要总结
The main end point of the study is to assess survival in cirrhotic patients with refractory ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis + albumin infusion.
详细描述
Diagnostic evaluation before randomisation includes assessment of clinical hepatic encephalopathy, usual blood tests, and Doppler-ultrasonography of the abdomen. Inclusion and exclusion criteria will be checked during the inclusion visit. Informations concerning the trial will also be given. After the investigator receives written informed consent, randomisation will be performed online. Randomisation will be centralized, equilibrated for each center, stratified according to whether cirrhosis is alcoholic or not and adjusted every ten patients.
I Treatments
- TIPS :
TIPS will be performed under sedation or general anesthesia with tracheal intubation according to the usual policy of participating centers. Pre-tips portosystemic pressure gradient and diameter of the shunt must be notified.
However, for homogeneity reasons the following will be adhered:
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
- •patients of both sexes, with cirrhosis, as documented by previous liver-biopsy or usual clinical and biochemical stigmata
- •with refractory or recurrent ascites as defined in chapter IV
- •who signed the informed consent form
排除标准
- •patients not fulfilling inclusion criteria
- •patients having needed more than 6 paracenteses within the last 3 months
- •patients expected to be transplanted within the next 6 months
- •usual contra-indication for TIPS : congestive heart failure NYHA>III or medical history of pulmonary hypertension, portal vein thrombosis, hepatic polycystosis, intra-hepatic bile ducts dilatation, spontaneous clinical recurrent hepatic encephalopathy
- •hepatocarcinoma on the expected tract of the shunt
- •severe liver failure as defined by : Prothrombin index < 35 % or total bilirubin > 100 micromol/l or Child Pugh Score >12
- •serum creatinine > 250 micromol/l
- •uncontrolled sepsis
- •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
Survival at one year
时间窗: one year
次要结局
- Quality of life, nutritional status, occurrence of complications (other than ascites) secondary to portal hypertension.(one year)