Clinical trial NCT03506893: Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Official title: Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ascites
Paracentesis
Cirrhosis
Keywords: refractory ascite
pump system
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 6 months and 1 year
measure: 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.
timeFrame: 6 months and 1 year
measure: 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.
timeFrame: 6 months and 1 year
measure: Evaluation of the clinical impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
timeFrame: 2 years
measure: Evaluation of the economic impact at 2 years of Alfapump® versus repeated evacuating paracentesis (prospective observational study).
timeFrame: 2 years
measure: Budget impact Analysis from the point of view of French health insurance, at 3 and 5 years.
timeFrame: 3 and 5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens-Picardie University Hospital
city: Angers
country: France
facility: Chu Angers
city: Besançon
country: France
facility: Jean MINJOZ Univesity Hospital
city: Bordeaux
country: France
facility: Haut-Lévêque Hospital
city: Clichy la garenne
country: France
facility: Beaujon Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Paris
country: France
facility: LA PITIE SALPETRIERE Univesity Hospital
city: Poitiers
country: France
facility: Chu Poitiers
city: Rennes
country: France
facility: Chu Pontchaillou
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Marie-Noelle HILLERET, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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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.
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.
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.