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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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 criteria

Qualifiers

Patient with refractory ascites who has had a minimum of 5 paracentesis in the last 3 months.

Patient with an estimated life expectancy of at least 6 months on the day of inclusion.

Patient with contraindication to the application of a TIPS or who has expressed a refusal of the procedure or a non-functional TIPS

Patient affiliated with or in receipt of social security

Disqualifiers

Local or systemic infection in the month preceding the procedure

Hepatocellular carcinoma with palliative care

MELD Score > 18

Child Pugh C Score > 10

Trial design

Treatments tested in this trial

  • Alphapump
  • Ascites puncture

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators