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Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Sponsor: University Hospital, Grenoble
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2018-07-17
Completion Date
2027-05-31
Last Updated
2025-03-30
Healthy Volunteers
No
Conditions
Interventions
Alphapump
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
Ascites puncture
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.
Locations (10)
Amiens-Picardie University Hospital
Amiens, France
Chu Angers
Angers, France
Jean MINJOZ Univesity Hospital
Besançon, France
Haut-Lévêque Hospital
Bordeaux, France
Beaujon Hospital
Clichy, France
Grenoble University Hospital
Grenoble, France
LA PITIE SALPETRIERE Univesity Hospital
Paris, France
Chu Poitiers
Poitiers, France
Chu Pontchaillou
Rennes, France
Toulouse University Hospital
Toulouse, France