Clinical studyProspective Evaluation of the PleurX Catheter When Used to Treat Recurrent Ascites Associated with Malignancy
Section snippets
Materials and Methods
This was a prospective study conducted at four institutions; the local institutional review board at each institution approved the study protocol. During the study period (March 2004 through April 2005), all patients who were potential candidates for the study based on the stated inclusionary/exclusionary criteria were asked to participate. We did not record the number of patients who declined to participate. Informed consent for the procedure and participation in the study was obtained in 36
Results
There were five patients who consented to and entered into the study who, in retrospect, represented protocol deviations. Four had undergone only one paracentesis in the previous 30 days rather than two. All four had symptomatic ascites and had relief of symptoms after drainage. Each patient continued to drain fluid after insertion of the catheter. Additionally, one patient who had multiple loculations and poor performance status was entered. All five are included in the analysis in the Results
Discussion
The main findings of the present work indicate that the PleurX catheter is a feasible approach to treat recurrent ascites associated with malignancy without significant rates of complication, failure, discomfort, or electrolyte abnormality. Specifically, we treated 34 subjects and demonstrated that all but five could use the catheter without failure. Also, of the 34, five had resolution of their ascites. Use of this device in these patients is, of course, palliative. All subjects had terminal
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Cited by (0)
This study was funded by Denver Biomedical, Inc. (Golden, Colorado). A.C. and S.R. have received consulting fees from Denver Biomedical and Cardinal Health (McGaw Park, Illinois). None of the other authors have identified a conflict of interest.