NCT03506893 Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
| NCT ID | NCT03506893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Ascites |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2018-07-17 |
| Primary Completion | 2025-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2018-07-17 with a primary completion date of 2025-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Marie-Noelle HILLERET, MD
PRINCIPAL INVESTIGATOR
University Hospital, Grenoble
Frequently Asked Questions
Who can join the NCT03506893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ascites. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03506893 currently recruiting?
Yes, NCT03506893 is actively recruiting participants. Contact the research team at sdavidtchouda@chu-grenoble.fr for enrollment information.
Where is the NCT03506893 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Besançon, France, Bordeaux, France and 6 additional locations.
Who is sponsoring the NCT03506893 clinical trial?
NCT03506893 is sponsored by University Hospital, Grenoble. The principal investigator is Marie-Noelle HILLERET, MD at University Hospital, Grenoble. The trial plans to enroll 90 participants.