Actively Recruiting
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Led by University Hospital, Grenoble · Updated on 2025-03-30
90
Participants Needed
10
Research Sites
462 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
-
Local or systemic infection in the month preceding the procedure
-
Hepatocellular carcinoma with palliative care
-
MELD Score > 18
-
Child Pugh C Score > 10
-
Creatinine Clearance < 50 ml/mn
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Digestive hemorrhage or episode of hepatic encephalopathy within two weeks prior to device insertion
-
Contraindication to general anesthesia
-
Contraindication to implant surgery of the device:
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Obstructive urological impairment
-
Partitioning of ascites
-
Coagulopathy
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Protected persons such as pregnant women, breastfeeding mothers, persons deprived of liberty, or under legal protection
-
Patient currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Amiens-Picardie University Hospital
Amiens, France, 80000
Actively Recruiting
2
Chu Angers
Angers, France, 49000
Actively Recruiting
3
Jean MINJOZ Univesity Hospital
Besançon, France, 25000
Actively Recruiting
4
Haut-Lévêque Hospital
Bordeaux, France, 33000
Not Yet Recruiting
5
Beaujon Hospital
Clichy, France, 92110
Actively Recruiting
6
Grenoble University Hospital
Grenoble, France, 38000
Actively Recruiting
7
LA PITIE SALPETRIERE Univesity Hospital
Paris, France, 75013
Actively Recruiting
8
Chu Poitiers
Poitiers, France, 86000
Not Yet Recruiting
9
Chu Pontchaillou
Rennes, France, 35000
Actively Recruiting
10
Toulouse University Hospital
Toulouse, France, 31000
Actively Recruiting
Research Team
S
Sandra DAVID-TCHOUDA, MD
CONTACT
S
Sandrine MASSICOT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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