Tunnelated Peritoneal Catheter Versus Repeated Large Volume Paracentesis for Diuretic Resistant Ascites in Patients With Cirrhosis: An Investigator Initiated, Open, Parallel Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Time to first paracentesis
研究概览
简要总结
Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small volume fluid drainage at home. The treatment may improve the management of ascites and have a beneficial effect on the quality of life.
This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic resistant ascites.
The trial is an investigator initiated, randomised, single blind, parallel arm, controlled trial.
Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will receive ciprofloxacin to prevent spontaneous bacterial peritonitis.
We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total duration of follow up is six months. The primary outcome is paracentesis free survival.
详细描述
Ten percent of patients with cirrhosis develop ascites. In 90% of patients, ascites can be treated with diuretics. The management of the remaining 10% with diuretic resistant ascites is challenging. Symptoms including abdominal pain, dyspnoea, nausea, vomiting, and anorexia have a detrimental impact on the quality of life. Repeated large volume paracentesis provides only temporary improvement of symptoms.
Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small volume fluid drainage at home. The treatment may improve the management of ascites and have a beneficial effect on the quality of life.
To evaluate the beneficial and harmful effects of the peritoneal catheter (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic resistant ascites.
Investigator initiated, randomised, single blind, parallel arm, controlled trial.
Due to the nature of the intervention and the primary outcome measure, Investigators are unable to conduct the trial with blinding of the patients, the investigators or use blinded outcome assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Cirrhosis of any aetiology
- •Diuretic resistant ascites defined as i) an inability to mobilise ascites (minimal or no weight loss) despite administration with the maximum tolerable doses of oral diuretics or a daily dose of spironolactone 400 mg and re-accumulation of fluid after therapeutic paracentesis within two weeks or ii) diuretic-related complications including (but not limited to) azotemia, hepatic encephalopathy, or progressive electrolyte imbalances
- •Able to read and understand Danish
- •Signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Male or female of any age
- •Age at least 18 years
- •Expected survival at least three months.
排除标准
- •Participants eligible and listed for TIPS
- •Serum creatinine levels above 135 umol/L
- •Overt hepatic encephalopathy in the two weeks before randomization
- •Ascites due to other causes than cirrhosis such as: malignant disease, congestive heart failure, end-stage renal disease, pancreatitis, or Budd-Chiari (hepatic vein thrombosis), or chylous ascites
- •Ongoing intra-abdominal infection (peritonitis) or active systemic or local infections, such as urinary tract infection or pneumonia
- •Participation in a clinical study that may interfere with participation in this study;
- •Evidence of extensive ascites loculation
- •Coagulopathy
- •Variceal bleeding within two weeks before randomisation
- •Intraabdominal surgery within four months before randomisation
- •Spontaneous bacterial peritonitis (neutrophil count>250/µl within 24 hours of randomization)
- •Patients with an increased risk of procedure related complications as judged by the primary healthcare provider
研究组 & 干预措施
PleurX
The PleurX catheter is a tunnelated peritoneal catheter, designed for permanent placement in the peritoneal cavity. The catheter is placed by a physician under sterile conditions. Drainage of ascites is done using vacuum bottles connected to the catheter. This can be managed by a home nurse or the patient.
干预措施: PleurX, peritoneal tunnelated catheter (Device)
PleurX
The PleurX catheter is a tunnelated peritoneal catheter, designed for permanent placement in the peritoneal cavity. The catheter is placed by a physician under sterile conditions. Drainage of ascites is done using vacuum bottles connected to the catheter. This can be managed by a home nurse or the patient.
干预措施: Ciprofloxacin 500Mg Tablet (Drug)
Large Volume Paracentesis
Large volume paracentesis is performed in sterile technique, a small incision is made through the skin, and a catheter is inserted through muscle and peritoneum. After the procedure, the patient remains in hospital for observation until the fluid is drained.
干预措施: Large Volume Paracentesis (Device)
Large Volume Paracentesis
Large volume paracentesis is performed in sterile technique, a small incision is made through the skin, and a catheter is inserted through muscle and peritoneum. After the procedure, the patient remains in hospital for observation until the fluid is drained.
干预措施: Ciprofloxacin 500Mg Tablet (Drug)
结局指标
主要结局
Time to first paracentesis
时间窗: 18 months
次要结局
- Adverse events(18 months)
- Nutritional Status(18 months)
- Cardiac Output(18 months)
- Renal function(18 months)
研究者
Nina Kimer
MD, PhD
Copenhagen University Hospital, Hvidovre