NCT02724683

Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Maciej Stukan, MD, PhD · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Ascites

Interventions

Type	Name	Description
DEVICE	Ascites drainage with vascular catheter.	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.
BEHAVIORAL	Interview.	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.
BEHAVIORAL	Quality of life.	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.
DEVICE	Quality of procedure.	Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure.
OTHER	Nutritional status	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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2016-03-31
• Last updated: 2023-02-23

Locations

2 sites across 2 countries: Czechia, Poland