An interventional study of Alphapump and Ascites puncture in Ascites, Paracentesis and Cirrhosis, sponsored by University Hospital, Grenoble. Recruiting at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
This study's planned enrollment of 90 is above the median of 54 across 179 interventional studies indexed under Ascites.
Browse Ascites studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
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Exclusion Criteria:
Contraindication to implant surgery of the device:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Alfapump® device implantation under general anesthesia (30-45 minutes)
Device: Alphapump
Iterative paracentesis compensated for by albumin infusions in ambulatory care.
Procedure: Ascites puncture
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
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 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.
Time frame: 1 year
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.
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.
Evaluation of the paracentesis-free survival, cirrhosis and device-related adverse events.
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.
Incremental cost-utility ratio.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 and 5 years
Plan to share: No
Started Jul 2018 (actual). Primary completion is estimated for Mar 2025, 80 months after the start.
Of 33 interventional studies with no phase under Ascites, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 62. This study's planned 80 months is above that.
How these figures are worked out, and which studies are left out of them.
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