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

Cirrhosis Clinical Trial

— ARIAPUMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506893
• Other study ID #: 38RC17.109
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: Sandra DAVID-TCHOUDA, MD
• Phone: +33 476 76 71 86
• Email: sdavidtchouda[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Cirrhosis
• Paracentesis

Intervention

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

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.

Locations

Country	Name	City	State
France	Amiens-Picardie University Hospital	Amiens
France	Chu Angers	Angers
France	Jean MINJOZ Univesity Hospital	Besançon
France	Haut-Lévêque Hospital	Bordeaux
France	Beaujon Hospital	Clichy la garenne
France	Grenoble University Hospital	Grenoble
France	LA PITIE SALPETRIERE Univesity Hospital	Paris
France	Chu Pontchaillou	Rennes
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & 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. — View 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® 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. — View Citation

Solà E, Solé C, Ginès P. Management of uninfected and infected ascites in cirrhosis. Liver Int. 2016 Jan;36 Suppl 1:109-15. doi: 10.1111/liv.13015. Review. — View 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® 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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