This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis \> 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Implanted ALFApump, removing produced ascites according to programmed schedule
Large volume paracentesis - standard of care, removing ascites according to patient need
Vienna General Hospital and Medical School, AKH
Vienna, Austria
Hopital Beaujon
Clichy, Paris, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Azienda Ospedaliera di Padova
Padua, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Bristol Royal Infirmary
Bristol, United Kingdom
Royal Free Hospital
London, United Kingdom
Paracentesis free survival
Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis \> 5 litres
Time frame: 6 months
Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system
Cirrhosis-related complications
Time frame: 6 months
Quality of Life
Time frame: 6 months
Body weight
Time frame: 6 months
Nutritional profile
Time frame: 6 months
Resource utilisation
Time frame: 6 months
Survival
Time frame: 6 months
Assess the need for repeat evacuation paracentesis
Time frame: 6 months
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