Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Ascites

Intervention / Treatment
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* Device: Ascites drainage with vascular catheter.
* Behavioral: Interview.
* Behavioral: Quality of life.
* Device: Quality of procedure.
* Other: Nutritional status


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with symptomatic, refractory malignant ascites, supportive care (professional or family members) available at patients' home, informed signed consent of the patient. Exclusion Criteria: ascites not of malignant origin, asymptomatic ascites, suspected or clinically apparent infection especially at the site of planned drainage placement, significant coagulopathy, very poor performance status (PS4), patient not able to read and sign informed consent, mucinous ascites.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic ascites drainage with CVC.<br>Patients with malignant, symptomatic, refractory ascites. Ascites drainage with vascular catheter (CVC) inserted into abdominal cavity will be performed. Patients will be asked to complete interview, quality of life questionnaire, nutritional status assessment and quality of procedure survey. | Device: Ascites drainage with vascular catheter.<br>* In case of symptomatic malignant ascites, the procedure of vascular catheter insertion into abdominal cavity will be performed, followed by slow, systematic drainage, on patient's demand.<br>Behavioral: Interview.<br>* Interview with patients will be performed according to attached chart. The aim is to collect data concerning patient's symptoms, co-morbidity, and basic clinical data about the primary malignancy and treatment status.<br>Behavioral: Quality of life.<br>* Quality of life questionnaire (QLQ). Patients will be asked to complete QLQ at two time points: 1. immediately before the procedure, 2. one or two weeks after the procedure.<br>Device: Quality of procedure.<br>* Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure.<br>Other: Nutritional status<br>* Risk of malnutrition and ability to feed normally will be assessed with specific questionnaire at two time points: 1. immediately before the procedure, 2. one or two weeks after the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events. | Early and late adverse events of the catheter placement and later drainage to be recorded. | 2 weeks | 
| Change in quality of life. | Change in quality of life measured with standard questionnaire EORTC-C15-PAL before the procedure and 1-2 weeks later. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with drainage complication during cancer treatment vs observation. | Assessment of possibilities to provide cancer treatment with active ascites drainage via catheter, by reporting number of participants with adverse events during chemotherapy or radiotherapy, whichever applies and comparison to observation (patients with palliative intent only, no active cancer treatment). | 1 month | 
| Number of participants with successful catheter placement. | From all eligible participants a number of participants with successful catheter placement followed by effective drainage will be recorded. | 2 weeks | 
| Patient's experience on the treatment. | Patient's experience on the treatment measured with standard questionnaire (FACIT-TS-G). | 2 weeks | 
| Change in nutrition habits. | Changes in ability to feed assessed in a descriptive way with the Subjective Global Assessment (SGA) questionnaire. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ascites, drainage, catheter, symptoms, management, quality of life, malignant, cancer