RecruitingNot ApplicableNCT03506893

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

Sponsor

University Hospital, Grenoble

Enrollment

90 participants

Start Date

Jul 17, 2018

Study Type

INTERVENTIONAL

Conditions

Cirrhosis Ascites Paracentesis

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria13

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
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:
Obstructive urological impairment
Partitioning of ascites
Coagulopathy
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).
Patient currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.

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Interventions

DEVICEAlphapump

Alfapump® device: a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder where they are eliminated by the urinary tract. Medical device marked CE, used in the indication provided for marking

PROCEDUREAscites puncture

Hospitalizations for evacuating ascites are performed at least twice a month and can be up to 2 times a week. A clinical and biological examination is carried out at each visit.