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

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ClinicalTrials.gov Identifier: NCT03506893
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Ascites Paracentesis Cirrhosis Device: Alphapump Procedure: Ascites puncture Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Alphapump
Alfapump® device implantation under general anesthesia (30-45 minutes)
 Device: Alphapump

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
Active Comparator: Ascites puncture
Iterative paracentesis compensated for by albumin infusions in ambulatory care.
 Procedure: Ascites 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.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of medical-economic impact at 1 year of 2 strategies: implantation of Alfapump® device versus repeated evacuating paracentesis (reference treatment) in cirrhotic patients with refractory ascites without programmed liver transplantation. [ Time Frame: 1 year ]
    Incremental cost-utility ratio (ICER) from societal perspective.


Secondary Outcome Measures :
  1. Comparison of the clinical impact at 6 and 12 months of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites WITHOUT programmed liver transplantation. [ Time Frame: 6 months and 1 year ]
    Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.

  2. Evaluation of the clinical impact at 6 and 12 months of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites WITH programmed liver transplantation. [ Time Frame: 6 months and 1 year ]
    Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.

  3. Evaluation of the economic impact at 6 and 12 months of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites WITH programmed liver transplantation. [ Time Frame: 6 months and 1 year ]
    Incremental cost-utility ratio.

  4. Evaluation of the clinical impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study). [ Time Frame: 2 years ]
    Evaluation of paracentesis-free survival, cirrhosis and device-related adverse events. We will analyse separately patients WITH and WITHOUT programmed liver transplantation.

  5. Evaluation of the economic impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study). [ Time Frame: 2 years ]
    Incremental cost-utility ratio. We will analyse separately patients WITH and WITHOUT programmed liver transplantation.

  6. Budget impact Analysis from the point of view of French health insurance, at 3 and 5 years. [ Time Frame: 3 and 5 years ]
    Economic consequences of the introduction of the Alfapump® device in the management strategies of cirrhotic patients presenting a refractory ascites.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with refractory ascites who has had a minimum of 8 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506893


Contacts
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Contact: Sandra DAVID-TCHOUDA, MD +33 476 76 71 86 sdavidtchouda@chu-grenoble.fr
Contact: Sandrine MASSICOT +33 476 76 88 60 smassicot@chu-grenoble.fr

Locations
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France
Amiens-Picardie University Hospital Recruiting
Amiens, France, 80000
Contact: Eric NGUYEN-KHAC, PhD       Nguyen-Khac.Eric@chu-amiens.fr   
Contact: Emilien COLIN    +333 22 08 88 67    colin.emilien@chu-amiens.fr   
Jean MINJOZ Univesity Hospital Not yet recruiting
Besançon, France, 25000
Contact: Thierry THEVENOT, PhD       tthevenot@chu-besancon.fr   
Contact: Emilie MUEL    +333 81 66 84 96    emuel@chu-besancon.fr   
Haut-Lévêque Hospital Not yet recruiting
Bordeaux, France, 33000
Contact: Victor DE LEDINGHEN, PhD       victor.deledinghen@chu-bordeaux.fr   
Contact: Maude CHARBONNIER    +335 57 65 63 11    maude.charbonnier@chu-bordeaux.fr   
Beaujon Hospital Recruiting
Clichy la garenne, France, 92110
Contact: Claire FRANCOZ, MD       claire.francoz@aphp.fr   
Contact: Vanessa ESNAULT    +33 140 87 50 64    vanessa.esnault@aphp.fr   
Grenoble University Hospital Recruiting
Grenoble, France, 38000
Contact: Marie-Noelle HILLERET, MD    +334 76 76 62 57    mnhilleret@chu-grenoble.fr   
LA PITIE SALPETRIERE Univesity Hospital Recruiting
Paris, France, 75013
Contact: Dominique THABUT       Dominique.thabut@aphp.fr   
Contact: Florence BERGERON       florence.bergeron@aphp.fr   
Chu Pontchaillou Recruiting
Rennes, France, 35000
Contact: Edouard BARDOU-JACQUET, PHD    0299284298    edouard.bardou-jacquet@chu-rennes.fr   
Contact: Solange SEGUIN    0299289889    Solange.SEGUIN@chu-rennes.fr   
Toulouse University Hospital Recruiting
Toulouse, France, 31000
Contact: Christophe BUREAU, PhD    +335 61 77 22 63    Bureau.c@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Marie-Noelle HILLERET, MD University Hospital, Grenoble
More Information
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Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03506893    
Other Study ID Numbers: 38RC17.109
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
refractory ascite
pump system
Additional relevant MeSH terms:
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Ascites
Pathologic Processes