An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis Secondary outcomes: Overall complications, quality of life, overall survival, and symptom control

Official Title
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An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites

Conditions
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Malignant Ascites

Intervention / Treatment
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* Procedure: paracentesis
* Device: Pleurx catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracentesis<br>cutting and draining procedure for malignant ascites | Procedure: paracentesis<br>* surgical drainage of malignant ascites<br>|
| Active Comparator: Pleurx catheter<br>a catheter drainage system the subject uses himself/herself. | Device: Pleurx catheter<br>* take home catheter drainage system that the subject uses himself/herself as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Pleurx Catheter or Paracentesis | 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. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleurx catheter, malignant ascites