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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 17, 2018
Primary Completion Date
March 25, 2025
Completion Date
May 31, 2027
Last Updated
March 30, 2025
90
ESTIMATED participants
Alphapump
DEVICE
Ascites puncture
PROCEDURE
Lead Sponsor
University Hospital, Grenoble
NCT05597488
NCT06932783
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06306963