Spots Global Cancer Trial Database for Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

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Trial Identification

Brief Title: Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

Official Title: Management of Symptomatic Malignant Ascites With an Patient-controlled, Vascular Catheter - a Validation Study.

Study ID: NCT02724683

Conditions

Malignant Ascites

Interventions

Ascites drainage with vascular catheter.

Interview.

Quality of life.

Quality of procedure.

Nutritional status

Study Description

Brief Summary: The purpose of this study is to determine whether drainage with the usage of a fine, patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and effective method in the management of symptomatic malignant ascites. Complications' rate of the procedure and patients' quality of life, nutritional status and experience on the treatment are main endpoints.

Detailed Description: Patients with symptomatic, refractory malignant ascites (MA) will be eligible for the study. In case a cancer treatment is not effective against ascites, or no target, systemic treatment is possible patients will be eligible for percutaneous placement of a vascular catheter into abdominal cavity followed be drainage performed in a regular basis when required, at home or ambulatory. Adult patients with every malignant disease, female and male, and coexisting symptomatic MA can be recruited. Clinical, quality of life (QOL) and quality of the procedure data will be collected. The study is planned to be a multiinstitutional. A template is provided to collect essential clinical data concerned with a patient, malignant disease, procedure performance and complications. QOL and patients' experience on the treatment is to be evaluated with formal questionnaires - EORTC C15-PAL and FACIT-TS-G - permission to use granted from EORTC and FACIT respectively. Additionally, a nutrition monitoring will be performed (if possible and feasible) in patients with MA and drainage. Data will be saved in a computer, secured data base for calculations. A cohort of 150 patients is planned to be collected. Duration of the study will depend on how many institutions will participate, and how fast patients will be recruited.