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

June 9, 2022 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80000
        • Recruiting
        • Amiens-Picardie University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric NGUYEN-KHAC, MDPHD
        • Sub-Investigator:
          • Jean-Marc REGIMBEAU, MDPHD
      • Angers, France, 49000
        • Not yet recruiting
        • Chu Angers
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frédéric OBERTI, MD PHD
        • Sub-Investigator:
          • Emilie LERMITE, MD
      • Besançon, France, 25000
        • Not yet recruiting
        • Jean MINJOZ Univesity Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thierry THEVENOT, MDPHD
      • Bordeaux, France, 33000
      • Clichy la garenne, France, 92110
      • Grenoble, France, 38000
        • Recruiting
        • Grenoble University Hospital
        • Contact:
      • Paris, France, 75013
      • Rennes, France, 35000
      • Toulouse, France, 31000
        • Recruiting
        • Toulouse University Hospital
        • Contact:
        • Principal Investigator:
          • Christophe BUREAU, MDPHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months and 1 year
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.
6 months and 1 year
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.
6 months and 1 year
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.
2 years
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.
2 years
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.
3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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