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

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: Cirrhosis; Paracentesis; Ascites

Treatments: Device: Alphapump; Procedure: Ascites puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03506893

38RC17.109

Details and patient eligibility

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Alphapump

Experimental group

Description:

Alfapump® device implantation under general anesthesia (30-45 minutes)

Treatment:

Device: Alphapump

Ascites puncture

Active Comparator group

Description:

Iterative paracentesis compensated for by albumin infusions in ambulatory care.

Treatment:

Procedure: Ascites puncture