Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Key facts
- Where
- Amiens, Angers, Besançon, Bordeaux, Clichy, Grenoble, Paris, Poitiers, Rennes, and Toulouse, FranceSee the 10 sites
Where in France
- Amiens-Picardie University HospitalAmiens, FranceContact: Eric NGUYEN-KHAC, MDPhDTaking people
- CHU AngersAngers, FranceContact: Frédéric OBERTI, MD PHDTaking people
- Jean MINJOZ Univesity HospitalBesançon, FranceContact: Thierry THEVENOT, MDPhDTaking people
- Haut-Lévêque HospitalBordeaux, FranceContact: Victor DE LEDINGHEN, MD PhDNot yet recruiting
- Beaujon HospitalClichy, FranceContact: Claire FRANCOZ, MDTaking people
- Grenoble University HospitalGrenoble, FranceContact: Marie-Noelle HILLERET, MDTaking people
- LA PITIE SALPETRIERE Univesity HospitalParis, FranceContact: Dominique THABUT, MDPHDTaking people
- CHU PoitiersPoitiers, FranceContact: Valentin ROLLE, MD PHDNot yet recruiting
- CHU PontchaillouRennes, FranceContact: Edouard BARDOU-JACQUET, MDPHDTaking people
- Toulouse University HospitalToulouse, FranceContact: Christophe BUREAU, MD PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Grenoble
- Trial code
- NCT03506893
- Record updated
- 30 March 2025
- Original description
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 separatelyRead full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Digestive hemorrhage or episode of hepatic encephalopathy within two weeks prior to device insertion; Patient currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion; Local or systemic infection in the month preceding the procedure; Contraindication to implant surgery of the device:; Obstructive urological impairment; Partitioning of ascites; Coagulopathy; Creatinine Clearance < 50 ml/mn; Hepatocellular carcinoma with palliative care; MELD Score > 18; Child Pugh C Score > 10; Contraindication to general anesthesia; Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure).