Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.
- Conditions
- Malignant Ascites
- Interventions
- Device: Ascites drainage with vascular catheter.Behavioral: Interview.Behavioral: Quality of life.Device: Quality of procedure.Other: Nutritional status
- Registration Number
- NCT02724683
- Lead Sponsor
- Maciej Stukan, MD, PhD
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- patients with symptomatic, refractory malignant ascites,
- supportive care (professional or family members) available at patients' home,
- informed signed consent of the patient.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Symptomatic ascites drainage with CVC. Interview. 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. Symptomatic ascites drainage with CVC. Ascites drainage with vascular catheter. 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. Symptomatic ascites drainage with CVC. Quality of life. 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. Symptomatic ascites drainage with CVC. Quality of procedure. 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. Symptomatic ascites drainage with CVC. Nutritional status 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.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events. 2 weeks Early and late adverse events of the catheter placement and later drainage to be recorded.
Change in quality of life. 2 weeks Change in quality of life measured with standard questionnaire EORTC-C15-PAL before the procedure and 1-2 weeks later.
- Secondary Outcome Measures
Name Time Method Patient's experience on the treatment. 2 weeks Patient's experience on the treatment measured with standard questionnaire (FACIT-TS-G).
Number of participants with successful catheter placement. 2 weeks From all eligible participants a number of participants with successful catheter placement followed by effective drainage will be recorded.
Number of participants with drainage complication during cancer treatment vs observation. 1 month 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).
Change in nutrition habits. 2 weeks Changes in ability to feed assessed in a descriptive way with the Subjective Global Assessment (SGA) questionnaire.
Trial Locations
- Locations (2)
Gdynia Oncology Center
🇵🇱Gdynia, Poland
The Central and Eastern European Gynecologic Oncology Group (CEEGOG)
🇨🇿Prague, Czechia