Clinical Trial: Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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 Summary:

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.

Sponsor: Maciej Stukan, MD, PhD

Current Primary Outcome:

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

Original Primary Outcome:

• Number of participants with successful catheter placement. [ Time Frame: 1 week ]
  From all eligible participants a number of participants with successful catheter placement followed by effective drainage will be recorded.
• Number of participants with adverse events. [ Time Frame: 2 weeks ]
  Early and late adverse events of the catheter placement and later drainage to be recorded.
• Change in quality of life. [ Time Frame: 2 weeks ]
  Change in quality of life measured with standard questionnaire EORTC-C15-PAL before the procedure and 1-2 weeks later.
• Patient's experience on the treatment. [ Time Frame: 2 weeks ]
  Patient's experience on the treatment measured with standard questionnaire (FACIT-TS-G).
• Change in nutrition status. [ Time Frame: 2 weeks ]
  Risk of malnutrition and ability to feed normally assessed with Subjective Global Assessment (SGA) questionnaire.

Current Secondary Outcome:

• Number of participants with drainage complication during cancer treatment vs observation. [ Time Frame: 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).
• Number of participants with successful catheter placement. [ Time Frame: 2 weeks ]
  From all eligible participants a number of participants with successful catheter placement followed by effective drainage will be recorded.
• Patient's experience on the treatment. [ Time Frame: 2 weeks ]
  Patient's experience on the treatment measured with standard questionnaire (FACIT-TS-G).
• Change in nutrition habits. [ Time Frame: 2 weeks ]
  Changes in ability to feed assessed in a descriptive way with the Subjective Global Assessment (SGA) questionnaire.

Original Secondary Outcome:

• Number of successful sclerotherapies of lymphocele via catheter. [ Time Frame: 1 month ]
  The rate of successful sclerotherapy of lymphocele via inserted catheter to be recorded.
• Number of participants with adverse events during cancer treatment and ascites drainage. [ Time Frame: 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.
• Change in nutrition status among participants with prolonged ascites drainage. [ Time Frame: 2 months ]
  Risk of malnutrition and ability to feed normally to be assessed with Subjective Global Assessment (SGA) questionnaire among participants with prolonged (1-2 months) ascites drainage.

Information By: Gdynia Oncology Center

Dates:
Date Received: March 20, 2016
Date Started: January 2016
Date Completion: December 2017
Last Updated: April 29, 2017
Last Verified: April 2017