An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis Or Early Intervention with Pleurx Catheters in Patients with Malignant Ascites
To assess in a controlled prospective setting, the safety of the use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.
Inclusion Criteria: (Patients can receive chemotherapy at the discretion of treating oncologist) 1.Patients with recurrent malignant ascites 2.Patients with refractory malignant ascites 3.Proven malignancy 4.Age greater than 18 years old 5.ECOG performance scale less than 2 6.Ability to understand and willingness to sign a written informed consent Definitions: Malignant ascites: One of the following criteria 1.Positive ascitic fluid cytology 2.Histology proven malignancy with imaging studies with evidence of liver metastasis and ascites 3.Malignant Budd Chiari Syndrome with associated ascites 4.Hepatocellular carcinoma and ascites 5.Chylous ascites due to lymphoma 6.Peritoneal carcinomatosis and concurrent ascites 7.Proven abdominal malignancy with concurrent ascites Refractory ascites: One of the following criteria 1.Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician. 2.Intolerance or relative contraindications to diuretics: (serum sodium (Na) concentration of less than 125 mmol per liter or serum creatinine greater than 1.5 mg/dl, hyperkalemia (potassium greater than 5.2 mEq/L or azotemia Bun/Creatinine ratio greater than 20). 3.Removal of at least 10 L in the preceding two months for symptoms relief Recurrent ascites: One of the following criteria 1.Symptomatic ascites that recurred on at least three occasions within a 2 month period despite diuretic treatment. Exclusion criteria: 1. Life expectancy less than one month 2. Coagulopathy (INR greater than 2 that does not correct with fresh frozen plasma) 3. Hepatorenal syndrome 4. Active skin infections at abdomen before procedures 5. Inability to provide inform consent 6. Platelet counts less than 50,000/mcL 7. Uncontrolled illness including, but not limited to, ongoing or active infection requiring IV antibiotics, that the physician feels would increase the risk of infection with the procedures or WBC count greater than 20,000/mcL 8. Absolute neutrophil count less than 1500 / cu mm 9. Pregnant women 10. Multiloculated ascites Definitions Survival: the time from randomization until death or loss to follow-up.
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. Outcomes: Primary Outcome: Safety of the pleurx catheter procedure or paracentesis Secondary outcomes: overall complications, quality of life, overall survival, and symptom control
05/21/2013 04:02 AM