NCT01528410已完成3 期
ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.
Sequana Medical N.V.8 个研究点 分布在 5 个国家目标入组 58 人开始时间: 2012年8月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Paracentesis free survival
研究概览
简要总结
This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant females (determined by serum pregnancy test) ≥ 18 years of age. Women of childbearing age must be prepared to use at least 1 effective (≤ 1% failure rate) method of contraception during the course of the study
- •Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria
- •Presenting refractory or recurrent ascites and requiring periodic large volume paracentesis (large volume defined as > 5 L to accord with teh clinical guidance of EASL, European Association for the Study of the Liver, which recommends withdrawal of 5 L should precipitate administration of albumin).
- •Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device
排除标准
- •Gastrointestinal haemorrhage over the last 7 days
- •Renal failure defined as serum creatinine higher than or equal to 2 mg/dl
- •Severe coagulopathy defined as prothrombin time greater than 40% more than upper limit of Normal (as determined locally).
- •Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery
- •Clinical Evidence of recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
- •Clinical evidence of recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
- •Clinical evidence of loculated ascites.
- •Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
- •Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
- •Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to, cardiac pacemaker or cardioverter defibrillator.
- •Pregnant females or females anticipating pregnancy during study period
- •Patients currently enrolled in another interventional clinical study
- •Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure)
- •Known presence of human immunodeficiency virus (HIV)
- •Immuno-modulatory treatment (including azothioprine, methotrexate, anti-TNF therapies) used within last 4 months
- •Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years
- •BMI > 40 presenting a risk for surgery and tunneled lines
- •Patients with contraindications for general anesthesia
结局指标
主要结局
Paracentesis free survival
时间窗: 6 months
Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis \> 5 litres
次要结局
- Survival(6 months)
- Nutritional profile(6 months)
- Quality of Life(6 months)
- Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system(6 months)
- Assess the need for repeat evacuation paracentesis(6 months)
- Body weight(6 months)
- Resource utilisation(6 months)
研究者
研究点 (8)
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