Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

Maciej Stukan, MD, PhD

Status: Enrolling

Conditions: Malignant Ascites

Treatments: Device: Ascites drainage with vascular catheter.; Device: Quality of procedure.; Behavioral: Interview.; Behavioral: Quality of life.; Other: Nutritional status

Study type: Observational

Funder types: Other

Identifiers

NCT02724683

GCO-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

170 participants in 1 patient group

Symptomatic ascites drainage with CVC.

Description:

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.

Treatment:

Device: Ascites drainage with vascular catheter.

Other: Nutritional status

Behavioral: Interview.

Device: Quality of procedure.

Behavioral: Quality of life.