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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT03506893
Collaborator
(none)
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Study Details

Study Description

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
  • Device: Alphapump
  • Procedure: Ascites puncture
N/A

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

Study Type:
Interventional
Anticipated 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 :
Jul 17, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

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. [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. [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. [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. [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). [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). [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. [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amiens-Picardie University Hospital Amiens France 80000
2 Chu Angers Angers France 49000
3 Jean MINJOZ Univesity Hospital Besançon France 25000
4 Haut-Lévêque Hospital Bordeaux France 33000
5 Beaujon Hospital Clichy la garenne France 92110
6 Grenoble University Hospital Grenoble France 38000
7 LA PITIE SALPETRIERE Univesity Hospital Paris France 75013
8 Chu Pontchaillou Rennes France 35000
9 Toulouse University Hospital Toulouse France 31000

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Marie-Noelle HILLERET, MD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT03506893
Other Study ID Numbers:
  • 38RC17.109
First Posted:
Apr 24, 2018
Last Update Posted:
Jun 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Grenoble
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022