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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Informed and written consent signed by the patient.

Locations
Other Locations
France
Amiens-Picardie University Hospital
RECRUITING
Amiens
Chu Angers
RECRUITING
Angers
Jean MINJOZ Univesity Hospital
RECRUITING
Besançon
Haut-Lévêque Hospital
NOT_YET_RECRUITING
Bordeaux
Beaujon Hospital
RECRUITING
Clichy
Grenoble University Hospital
RECRUITING
Grenoble
LA PITIE SALPETRIERE Univesity Hospital
RECRUITING
Paris
Chu Poitiers
NOT_YET_RECRUITING
Poitiers
Chu Pontchaillou
RECRUITING
Rennes
Toulouse University Hospital
RECRUITING
Toulouse
Contact Information
Primary
Sandra DAVID-TCHOUDA, MD
sdavidtchouda@chu-grenoble.fr
+33 476 76 71 86
Backup
Sandrine MASSICOT
smassicot@chu-grenoble.fr
+33 476 76 88 60
Time Frame
Start Date: 2018-07-17
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 90
Treatments
Experimental: Alphapump
Alfapump® device implantation under general anesthesia (30-45 minutes)
Active_comparator: Ascites puncture
Iterative paracentesis compensated for by albumin infusions in ambulatory care.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov

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