An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Safety of Pleurx Catheter or Paracentesis
研究概览
简要总结
The purpose of this study is to assess in a controlled prospective setting, the safety of the use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.
详细描述
Study Design: Single institution, open-label, randomized study
Study Device: Pleurx Catheter
Treatment Plan: Cohort A: 15 patients treated with standard therapy (therapeutic paracentesis +/- diuretics)
Cohort B: 15 patients treated with peritoneal Pleurx catheter
Duration of Participation: Patients will be followed for one year, or until death, whichever comes first.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Patients can receive chemotherapy at the discretion of treating oncologist)
- •Patients with recurrent malignant ascites
- •Patients with refractory malignant ascites
- •Proven malignancy
- •Age >= 18 years old
- •Eastern Cooperative Oncology Group (ECOG) performance scale =< 2
- •Ability to understand and willingness to sign a written informed consent
- •Definitions:
- •Malignant ascites: One of the following criteria
- •Positive ascitic fluid cytology
- •Histology proven malignancy with imaging studies with evidence of liver metastasis and ascites
- •Malignant Budd Chiari Syndrome with associated ascites
- •Hepatocellular carcinoma and ascites
- •Chylous ascites due to lymphoma
- •Peritoneal carcinomatosis and concurrent ascites
- •Proven abdominal malignancy with concurrent ascites
- •Refractory / Recurrent ascites: One of the following criteria
- •Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites.
- •Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician.
- •Intolerance or relative contraindications to diuretics: (serum sodium (Na) concentration of <125 mmol per liter or serum creatinine >1.5 mg/dl, hyperkalemia (potassium >5.2 mEq/L or azotemia Bun/Creatinine ratio > 20).
- •Removal of at least 5 L in the preceding two months for symptoms relief
- •Exclusion criteria:
- •Life expectancy less than one month
- •Coagulopathy (international normalized ratio [INR] > 2 that does not correct with fresh frozen plasma)
- •Hepatorenal syndrome
- •Active skin infections at abdomen before procedures
- •Inability to provide inform consent
- •Platelet counts < 50,000/mcL
- •Uncontrolled illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, that the physician feels would increase the risk of infection with the procedures or white blood cell (WBC) count > 20,000/mcL
- •Absolute neutrophil count <1000 / cu mm
- •Pregnant women
- •Multiloculated ascites
排除标准
- 未提供
结局指标
主要结局
Safety of Pleurx Catheter or Paracentesis
时间窗: 3 years
Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis Safety of the pleurx catheter procedure or paracentesis. Safety will be assessed by the degree of unacceptable toxicities, defined as life threatening complications related to the procedure. These include peritonitis, perforation, or death related to the procedure.
次要结局
未报告次要终点