NCT03506893

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2018May 2027

First Submitted

Initial submission to the registry

March 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 17, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Expected
Last Updated

March 30, 2025

Status Verified

December 1, 2024

Enrollment Period

6.7 years

First QC Date

March 8, 2018

Last Update Submit

March 25, 2025

Conditions

AscitesParacentesisCirrhosis

Keywords

refractory ascitepump system

Outcome Measures

Primary Outcomes (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.

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

    1 year

Secondary Outcomes (6)

  • 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 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 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

  • Evaluation of the clinical impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).

    2 years

  • Evaluation of the economic impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Alphapump

EXPERIMENTAL

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

Device: Alphapump

Ascites puncture

ACTIVE COMPARATOR

Iterative paracentesis compensated for by albumin infusions in ambulatory care.

Procedure: Ascites puncture

Interventions

AlphapumpDEVICE

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

Alphapump
Ascites puncturePROCEDURE

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.

Ascites puncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with refractory ascites who has had a minimum of 5 paracentesis in the last 3 months.
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Amiens-Picardie University Hospital

Amiens, 80000, France

RECRUITING

Chu Angers

Angers, 49000, France

RECRUITING

Jean MINJOZ Univesity Hospital

Besançon, 25000, France

RECRUITING

Haut-Lévêque Hospital

Bordeaux, 33000, France

NOT YET RECRUITING

Beaujon Hospital

Clichy, 92110, France

RECRUITING

Grenoble University Hospital

Grenoble, 38000, France

RECRUITING

LA PITIE SALPETRIERE Univesity Hospital

Paris, 75013, France

RECRUITING

Chu Poitiers

Poitiers, 86000, France

NOT YET RECRUITING

Chu Pontchaillou

Rennes, 35000, France

RECRUITING

Toulouse University Hospital

Toulouse, 31000, France

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23318604BACKGROUND

  • 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.

    PMID: 28645737BACKGROUND

  • 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.

    PMID: 28940225BACKGROUND

  • 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.

    PMID: 26725907BACKGROUND

  • 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.

    PMID: 26566989BACKGROUND

  • 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.

    PMID: 29460201BACKGROUND

MeSH Terms

Conditions

AscitesFibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Noelle HILLERET, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra DAVID-TCHOUDA, MD

CONTACT

+33 476 76 71 86sdavidtchouda@chu-grenoble.fr

Sandrine MASSICOT

CONTACT

+33 476 76 88 60smassicot@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

April 24, 2018

Study Start

July 17, 2018

Primary Completion

March 25, 2025

Study Completion (Estimated)

May 31, 2027

Last Updated

March 30, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)