Automated low flow pump system for the treatment of refractory ascites: a multi-center safety and efficacy study.
Pablo Bellot, Martin-Walter Welker, German Soriano...
https://pubmed.ncbi.nlm.nih.gov/23318604Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03506893
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump4 Device in Cirrhotic Patients
Led by University Hospital, Grenoble · Updated on 2025-03-30
90
Participants Needed
10
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the medical and economic impact of two treatment strategies for patients with refractory ascites caused by cirrhosis: implantation of the Alfapump4 device versus repeated evacuating paracentesis. This study focuses on patients both awaiting and not awaiting liver transplantation, assessing quality-adjusted life years (QALYs) and overall costs related to treatment and complications over one year. The Alfapump4 is a fully implanted device placed under the skin that moves ascites fluid from the abdomen to the bladder for removal through urination. One group of patients receives this device implantation under general anesthesia, while the comparison group undergoes repeated ascites drainage through paracentesis performed in outpatient care, with albumin infusions to compensate fluid loss. The trial follows patients for up to two years, including evaluations at 6, 12, and 24 months, and also considers long-term economic effects up to five years. Participants will be monitored through clinical and biological examinations during their visits, with assessments of medical and economic outcomes. The primary measure is the cost-effectiveness of the Alfapump4 device compared to paracentesis after one year. Secondary outcomes include clinical impacts and budget analyses over varying timeframes. The study includes safety monitoring and continues until May 2027, with all care and treatments provided under medical supervision.
CONDITIONS
Brief Title
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient with refractory ascites who has had at least 5 paracentesis in the last 3 months
- Estimated life expectancy of at least 6 months on the day of inclusion
- Contraindication to TIPS procedure or refusal of TIPS or non-functional TIPS
- Affiliated with or receiving social security
- Signed informed and written consent
You will not qualify if you...
- Local or systemic infection in the month before the procedure
- Hepatocellular carcinoma with palliative care
- MELD score greater than 18
- Child Pugh C score greater than 10
- Creatinine clearance below 50 ml/min
- Digestive hemorrhage or hepatic encephalopathy within 2 weeks before device insertion
- Contraindication to general anesthesia
- Contraindication to device implant surgery (obstructive urological impairment, partitioning of ascites, coagulopathy)
- Pregnant, breastfeeding, deprived of liberty, or under legal protection
- Participation in another clinical trial within 1 month prior to inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single procedure with recovery period
Participants receive implantation of the Alfapump® device under general anesthesia, which mobilizes ascites from the peritoneal cavity to the bladder for elimination.
1 implantation visit (in-person)
Post-operative Follow-up
Duration - Up to 1 year
Participants are monitored after device implantation to assess clinical outcomes and manage any complications.
Regular visits as needed during follow-up
Ascites Puncture Treatment
Duration - Up to 1 year
Participants undergo repeated ascites punctures in ambulatory care to evacuate fluid with clinical and biological examinations at each visit.
At least twice a month, up to 2 times a week visits (in-person)
Trial Site Locations
Total: 10 locations
1
Amiens-Picardie University Hospital
Amiens, France, 80000
Actively Recruiting
2
Chu Angers
Angers, France, 49000
Actively Recruiting
3
Jean MINJOZ Univesity Hospital
Besançon, France, 25000
Actively Recruiting
4
Haut-Lévêque Hospital
Bordeaux, France, 33000
Not Yet Recruiting
5
Beaujon Hospital
Clichy, France, 92110
Actively Recruiting
6
Grenoble University Hospital
Grenoble, France, 38000
Actively Recruiting
7
LA PITIE SALPETRIERE Univesity Hospital
Paris, France, 75013
Actively Recruiting
8
Chu Poitiers
Poitiers, France, 86000
Not Yet Recruiting
9
Chu Pontchaillou
Rennes, France, 35000
Actively Recruiting
10
Toulouse University Hospital
Toulouse, France, 31000
Actively Recruiting
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Research Team
S
Sandra DAVID-TCHOUDA, MD
S
Sandrine MASSICOT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study.
Christophe Bureau, Danielle Adebayo, Mael Chalret de Rieu...
https://pubmed.ncbi.nlm.nih.gov/28645737Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis.
G Stirnimann, T Berg, L Spahr...
https://pubmed.ncbi.nlm.nih.gov/28940225Management of uninfected and infected ascites in cirrhosis.
Elsa Solà, Cristina Solé, Pere Ginès
https://pubmed.ncbi.nlm.nih.gov/26725907Automated low flow pump system for the treatment of refractory ascites: a single-center experience.
M N Thomas, G H Sauter, A L Gerbes...
https://pubmed.ncbi.nlm.nih.gov/26566989Patients 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.
Maria Stepanova, Fatema Nader, Christophe Bureau...
https://pubmed.ncbi.nlm.nih.gov/29460201