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

Stopped early · Not applicable

Conditions studied: Malignant Ascites

In brief

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.

Key facts

Study ID

NCT01077063

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

7

Starts

2010-02-01

Expected to finish

2013-08-01

Last updated by the study team

2015-10-29

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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

You may not qualify if…

• 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

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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