Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Evaluation 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. — 1 year
  Incremental cost-utility ratio (ICER) from societal perspective.

Trial sites (10)

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