The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs generated , and that the cost of Alfapump® device and its implantation will be totally or partially offset by the reduction in the number of evacuating parentheses performed and the reduction in the number of complications in patients with refractory ascites awaiting liver transplantation or not. On the other hand, given the difference in the clinical profiles of these two populations (whether or not they are awaiting transplantation), these two populations will be study separately Evaluation of the medical-economic impact at 1 year of the two therapeutic strategies: implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites without scheduled liver transplantation.
Refractory ascites is one of the complications associated with portal hypertension in the cirrhotic patient. To date, its treatment consists of evacuating punctures, performed in day hospitalisation, whose frequency is adapted to the rate of ascites synthetis. Paracentesis, which does not affect the mechanisms of ascites formation, contributes to protein catabolism and undernutrition. They also have an inconvenience linked to the gesture, making frequent hospital stays necessary. For all these reasons, the patient's quality of life is diminished. The Alfapump® system is a new method for the treatment of refractory ascites. It is a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder, where ascites is eliminated by urinary tract.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Alfapump® device: a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder where they are eliminated by the urinary tract. Medical device marked CE, used in the indication provided for marking
Hospitalizations for evacuating ascites are performed at least twice a month and can be up to 2 times a week. A clinical and biological examination is carried out at each visit.
Amiens-Picardie University Hospital
Amiens, France
RECRUITINGChu Angers
Angers, France
RECRUITINGJean MINJOZ Univesity Hospital
Besançon, France
RECRUITINGHaut-Lévêque Hospital
Bordeaux, France
NOT_YET_RECRUITINGBeaujon Hospital
Clichy, France
RECRUITINGGrenoble University Hospital
Grenoble, France
RECRUITINGLA PITIE SALPETRIERE Univesity Hospital
Paris, France
RECRUITINGChu Poitiers
Poitiers, France
NOT_YET_RECRUITINGChu Pontchaillou
Rennes, France
RECRUITINGToulouse University Hospital
Toulouse, France
RECRUITINGEvaluation of medical-economic impact at 1 year of 2 strategies: implantation of Alfapump® device versus repeated evacuating paracentesis (reference treatment) in cirrhotic patients with refractory ascites without programmed liver transplantation.
Incremental cost-utility ratio (ICER) from societal perspective.
Time frame: 1 year
Comparison of the clinical impact at 6 and 12 months of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites WITHOUT programmed liver transplantation.
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
Time frame: 6 months and 1 year
Evaluation of the clinical impact at 6 and 12 months of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites WITH programmed liver transplantation.
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
Time frame: 6 months and 1 year
Evaluation of the economic impact at 6 and 12 months of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites WITH programmed liver transplantation.
Incremental cost-utility ratio.
Time frame: 6 months and 1 year
Evaluation of the clinical impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
Evaluation of paracentesis-free survival, cirrhosis and device-related adverse events. We will analyse separately patients WITH and WITHOUT programmed liver transplantation.
Time frame: 2 years
Evaluation of the economic impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
Incremental cost-utility ratio. We will analyse separately patients WITH and WITHOUT programmed liver transplantation.
Time frame: 2 years
Budget impact Analysis from the point of view of French health insurance, at 3 and 5 years.
Economic consequences of the introduction of the Alfapump® device in the management strategies of cirrhotic patients presenting a refractory ascites.
Time frame: 3 and 5 years
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