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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alphapump | Experimental | Alfapump® device implantation under general anesthesia (30-45 minutes) |
|
| Ascites puncture | Active Comparator | Iterative paracentesis compensated for by albumin infusions in ambulatory care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alphapump | Device | 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 |
| 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. | Incremental cost-utility ratio (ICER) from societal perspective. | 1 year |
| 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. | Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events. | 6 months and 1 year |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra DAVID-TCHOUDA, MD | Contact | +33 476 76 71 86 | sdavidtchouda@chu-grenoble.fr | |
| Sandrine MASSICOT | Contact | +33 476 76 88 60 | smassicot@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Noelle HILLERET, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens-Picardie University Hospital | Recruiting | Amiens | 80000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23318604 | Background | 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. | |
| 28645737 |
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|
| Ascites puncture | Procedure | 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. |
|
| 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. |
| 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. | 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. | 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. | 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. | 3 and 5 years |
| Chu Angers | Recruiting | Angers | 49000 | France |
|
| Jean MINJOZ Univesity Hospital | Recruiting | Besançon | 25000 | France |
|
| Haut-Lévêque Hospital | Not yet recruiting | Bordeaux | 33000 | France |
|
| Beaujon Hospital | Recruiting | Clichy | 92110 | France |
|
| Grenoble University Hospital | Recruiting | Grenoble | 38000 | France |
|
| LA PITIE SALPETRIERE Univesity Hospital | Recruiting | Paris | 75013 | France |
|
| Chu Poitiers | Not yet recruiting | Poitiers | 86000 | France |
|
| Chu Pontchaillou | Recruiting | Rennes | 35000 | France |
|
| Toulouse University Hospital | Recruiting | Toulouse | 31000 | France |
|
| Background |
| 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. |
| 28940225 | Background | 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. |
| 26725907 | Background | 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. |
| 26566989 | Background | 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. |
| 29460201 | Background | 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. |
| ID | Term |
|---|---|
| D001201 | Ascites |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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