AscitesARIAPUMPNCT03506893
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
A study testing Alphapump and Ascites puncture in people with Ascites and Paracentesis, run by University Hospital, Grenoble at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites, Paracentesis, Cirrhosis
- What is being tested?
- Alphapump and Ascites puncture
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 10 sitesFrance
- Study dates
- 17 Jul 2018to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Amiens-Picardie University Hospital
Amiens, 80000
Eric NGUYEN-KHAC, MDPhD, Nguyen-Khac.Eric@chu-amiens.fr
Rachida FAHEM, +333 22 08 88 67, fahem.rachida@chu-amiens.fr
- Recruiting
Chu Angers
Angers, 49000
Frédéric OBERTI, MD PHD, foberti@chu-angers.fr
Pierre CELEA, pierre.celea@chu-angers.fr
- Recruiting
Jean MINJOZ Univesity Hospital
Besançon, 25000
Thierry THEVENOT, MDPhD, tthevenot@chu-besancon.fr
Emilie MUEL, +333 81 66 84 96, emuel@chu-besancon.fr
- Not yet recruiting
Haut-Lévêque Hospital
Bordeaux, 33000
Victor DE LEDINGHEN, MD PhD, victor.deledinghen@chu-bordeaux.fr
Maude CHARBONNIER, +335 57 65 63 11, maude.charbonnier@chu-bordeaux.fr
- Recruiting
Beaujon Hospital
Clichy, 92110
Claire FRANCOZ, MD, claire.francoz@aphp.fr
Vanessa ESNAULT, +33 140 87 50 64, vanessa.esnault@aphp.fr
- Recruiting
Grenoble University Hospital
Grenoble, 38000
Marie-Noelle HILLERET, MD, +334 76 76 62 57, mnhilleret@chu-grenoble.fr
- Recruiting
LA PITIE SALPETRIERE Univesity Hospital
Paris, 75013
Dominique THABUT, MDPHD, Dominique.thabut@aphp.fr
Florence BERGERON, florence.bergeron@aphp.fr
- Not yet recruiting
Chu Poitiers
Poitiers, 86000
Valentin ROLLE, MD PHD, Valentin.ROLLE@chu-poitiers.fr
Laetitia ROULEAU, laetitia.rouleau@chu-poitiers.fr
- Recruiting
Chu Pontchaillou
Rennes, 35000
Edouard BARDOU-JACQUET, MDPHD, 0299284298, edouard.bardou-jacquet@chu-rennes.fr
Solange SEGUIN, 0299289889, Solange.SEGUIN@chu-rennes.fr
- Recruiting
Toulouse University Hospital
Toulouse, 31000
Christophe BUREAU, MD PhD, +335 61 77 22 63, Bureau.c@chu-toulouse.fr
Christophe BUREAU, MDPHD
About this study
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.
Read the 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.
- Conditions
- Ascites, Paracentesis, Cirrhosis
- Being tested
- Alphapump, Ascites puncture
- Keywords
- refractory ascite, pump system
- Medical subject headings
- Ascites, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Ascites punctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Alphapump | Experimental | Alfapump® device implantation under general anesthesia (30-45 minutes) Receives: Device: Alphapump |
| Ascites puncture | Active comparator | Iterative paracentesis compensated for by albumin infusions in ambulatory care. Receives: Procedure: Ascites puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
Measured: 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.
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
Measured: 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.
Incremental cost-utility ratio.
Measured: 6 months and 1 year
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start17 Jul 2018
- Primary completion25 Mar 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Noelle HILLERET, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506893
- Sponsor's protocol ID
- 38RC17.109
- Acronym
- ARIAPUMP
- Status last verified
- Dec 2024
- First submitted
- 8 Mar 2018
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23318604Bureau 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.
PubMed 28645737Stirnimann 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.
PubMed 28940225Sola 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.
PubMed 26725907Thomas 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.
PubMed 26566989Stepanova 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.
PubMed 29460201
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT03506893
- Acronym / sponsor ID
- ARIAPUMP / 38RC17.109
- Conditions
- Ascites, Paracentesis, Cirrhosis
- Keywords
- refractory ascite, pump system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alphapump | Experimental | Device: AlphapumpAlfapump® device implantation under general anesthesia (30-45 minutes) |
| Ascites puncture | Active comparator | Procedure: Ascites punctureIterative paracentesis compensated for by albumin infusions in ambulatory care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlphapumpAlfapump® 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 | Device | Alphapump |
| Ascites punctureHospitalizations 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. | Procedure or surgery | Ascites puncture |
Primary outcome
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.
6 secondary outcomes
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 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 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
Evaluation of the clinical impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
Time frame: 2 years
Evaluation of the economic impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 23318604Bellot 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.
- Background: PubMed 28645737Bureau 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.
- Background: PubMed 28940225Stirnimann 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.
- Background: PubMed 26725907Sola 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.
- Background: PubMed 26566989Thomas 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.
- Background: PubMed 29460201Stepanova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Noelle HILLERET, MD principal investigator
University Hospital, Grenoble
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alphapump and Ascites puncture in people with Ascites and Paracentesis, run by University Hospital, Grenoble at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra DAVID-TCHOUDA, MD (+33 476 76 71 86, sdavidtchouda@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506893, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.