Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device… (NCT03506893) | Clinical Trial Compass
RecruitingNot Applicable
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
France90 participantsStarted 2018-07-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.