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

Primary Purpose

Ascites, Paracentesis, Cirrhosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Alphapump
Ascites puncture
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascites focused on measuring refractory ascite, pump system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Amiens-Picardie University HospitalRecruiting
  • Chu Angers
  • Jean MINJOZ Univesity Hospital
  • Haut-Lévêque Hospital
  • Beaujon HospitalRecruiting
  • Grenoble University HospitalRecruiting
  • LA PITIE SALPETRIERE Univesity HospitalRecruiting
  • Chu PontchaillouRecruiting
  • Toulouse University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alphapump

Ascites puncture

Arm Description

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

Iterative paracentesis compensated for by albumin infusions in ambulatory care.

Outcomes

Primary Outcome Measures

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.
Incremental cost-utility ratio (ICER) from societal perspective.

Secondary Outcome Measures

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.
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
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.
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
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.
Incremental cost-utility ratio.
Evaluation of the clinical impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
Evaluation of paracentesis-free survival, cirrhosis and device-related adverse events. We will analyse separately patients WITH and WITHOUT programmed liver transplantation.
Evaluation of the economic impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
Incremental cost-utility ratio. We will analyse separately patients WITH and WITHOUT programmed liver transplantation.
Budget impact Analysis from the point of view of French health insurance, at 3 and 5 years.
Economic consequences of the introduction of the Alfapump® device in the management strategies of cirrhotic patients presenting a refractory ascites.

Full Information

First Posted
March 8, 2018
Last Updated
June 9, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03506893
Brief Title
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Acronym
ARIAPUMP
Official Title
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Paracentesis, Cirrhosis
Keywords
refractory ascite, pump system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alphapump
Arm Type
Experimental
Arm Description
Alfapump® device implantation under general anesthesia (30-45 minutes)
Arm Title
Ascites puncture
Arm Type
Active Comparator
Arm Description
Iterative paracentesis compensated for by albumin infusions in ambulatory care.
Intervention Type
Device
Intervention Name(s)
Alphapump
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Ascites puncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Incremental cost-utility ratio (ICER) from societal perspective.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Description
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
Time Frame
6 months and 1 year
Title
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.
Description
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
Time Frame
6 months and 1 year
Title
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.
Description
Incremental cost-utility ratio.
Time Frame
6 months and 1 year
Title
Evaluation of the clinical impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
Description
Evaluation of paracentesis-free survival, cirrhosis and device-related adverse events. We will analyse separately patients WITH and WITHOUT programmed liver transplantation.
Time Frame
2 years
Title
Evaluation of the economic impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
Description
Incremental cost-utility ratio. We will analyse separately patients WITH and WITHOUT programmed liver transplantation.
Time Frame
2 years
Title
Budget impact Analysis from the point of view of French health insurance, at 3 and 5 years.
Description
Economic consequences of the introduction of the Alfapump® device in the management strategies of cirrhotic patients presenting a refractory ascites.
Time Frame
3 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra DAVID-TCHOUDA, MD
Phone
+33 476 76 71 86
Email
sdavidtchouda@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sandrine MASSICOT
Phone
+33 476 76 88 60
Email
smassicot@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Noelle HILLERET, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens-Picardie University Hospital
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric NGUYEN-KHAC, MDPhD
Email
Nguyen-Khac.Eric@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Rachida FAHEM
Phone
+333 22 08 88 67
Email
fahem.rachida@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Eric NGUYEN-KHAC, MDPHD
First Name & Middle Initial & Last Name & Degree
Jean-Marc REGIMBEAU, MDPHD
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric OBERTI, MD PHD
Email
foberti@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Pierre CELEA
Email
pierre.celea@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Frédéric OBERTI, MD PHD
First Name & Middle Initial & Last Name & Degree
Emilie LERMITE, MD
Facility Name
Jean MINJOZ Univesity Hospital
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry THEVENOT, MDPhD
Email
tthevenot@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Emilie MUEL
Phone
+333 81 66 84 96
Email
emuel@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Thierry THEVENOT, MDPHD
Facility Name
Haut-Lévêque Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor DE LEDINGHEN, MD PhD
Email
victor.deledinghen@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Maude CHARBONNIER
Phone
+335 57 65 63 11
Email
maude.charbonnier@chu-bordeaux.fr
Facility Name
Beaujon Hospital
City
Clichy la garenne
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire FRANCOZ, MD
Email
claire.francoz@aphp.fr
First Name & Middle Initial & Last Name & Degree
Vanessa ESNAULT
Phone
+33 140 87 50 64
Email
vanessa.esnault@aphp.fr
First Name & Middle Initial & Last Name & Degree
Claire FRANCOZ
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Noelle HILLERET, MD
Phone
+334 76 76 62 57
Email
mnhilleret@chu-grenoble.fr
Facility Name
LA PITIE SALPETRIERE Univesity Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique THABUT, MDPHD
Email
Dominique.thabut@aphp.fr
First Name & Middle Initial & Last Name & Degree
Florence BERGERON
Email
florence.bergeron@aphp.fr
First Name & Middle Initial & Last Name & Degree
Dominique THABUT, MDPHD
Facility Name
Chu Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard BARDOU-JACQUET, MDPHD
Phone
0299284298
Email
edouard.bardou-jacquet@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Solange SEGUIN
Phone
0299289889
Email
Solange.SEGUIN@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Edouard BARDOU-JACQUET, MDPHD
First Name & Middle Initial & Last Name & Degree
Caroline JEZEQUEL, MD
Facility Name
Toulouse University Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BUREAU, MD PhD
Phone
+335 61 77 22 63
Email
Bureau.c@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Christophe BUREAU, MDPHD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23318604
Citation
Bellot P, Welker MW, Soriano G, von Schaewen M, Appenrodt B, Wiest R, Whittaker S, Tzonev R, Handshiev S, Verslype C, Moench C, Zeuzem S, Sauerbruch T, Guarner C, Schott E, Johnson N, Petrov A, Katzarov K, Nevens F, Zapater P, Such J. Automated low flow pump system for the treatment of refractory ascites: a multi-center safety and efficacy study. J Hepatol. 2013 May;58(5):922-7. doi: 10.1016/j.jhep.2012.12.020. Epub 2013 Jan 11.
Results Reference
background
PubMed Identifier
28645737
Citation
Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump(R) system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21. Erratum In: J Hepatol. 2018 Jan 29;: J Hepatol. 2020 Mar;72(3):595-596.
Results Reference
background
PubMed Identifier
28940225
Citation
Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Stallmach A, Engelmann C, Trepte C, Capel J, De Gottardi A. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Nov;46(10):981-991. doi: 10.1111/apt.14331. Epub 2017 Sep 21.
Results Reference
background
PubMed Identifier
26725907
Citation
Sola E, Sole C, Gines P. Management of uninfected and infected ascites in cirrhosis. Liver Int. 2016 Jan;36 Suppl 1:109-15. doi: 10.1111/liv.13015.
Results Reference
background
PubMed Identifier
26566989
Citation
Thomas MN, Sauter GH, Gerbes AL, Stangl M, Schiergens TS, Angele M, Werner J, Guba M. Automated low flow pump system for the treatment of refractory ascites: a single-center experience. Langenbecks Arch Surg. 2015 Dec;400(8):979-83. doi: 10.1007/s00423-015-1356-1. Epub 2015 Nov 13.
Results Reference
background
PubMed Identifier
29460201
Citation
Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump(R) system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19.
Results Reference
background

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

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