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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
surgical drainage of malignant ascites
take home catheter drainage system that the subject uses himself/herself as needed.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
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.
Time frame: 3 years
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