UnknownNot Applicable

Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

Czechia, Poland170 participantsStarted 2016-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of participants with adverse events.

Timeframe: 2 weeks

Change in quality of life.

Timeframe: 2 weeks

Trial details

NCT IDNCT02724683

SponsorMaciej Stukan, MD, PhD

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-08

Contact for this trial

Maciej Stukan, MD

+48692112481 mstukan@szpital-morski.pl

View on ClinicalTrials.gov More Malignant Ascites trials