Evaluation of the Alfapump® device for treating refractory ascites in cirrhotic patients
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
NA · University Hospital, Grenoble · NCT03506893
This study is testing if the Alfapump® device can help people with cirrhosis and fluid buildup feel better and reduce hospital visits compared to the usual treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble (other) |
| Locations | 10 sites (Amiens and 9 other locations) |
| Trial ID | NCT03506893 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and cost-effectiveness of the Alfapump® device compared to traditional paracentesis in patients with refractory ascites due to cirrhosis. The Alfapump® is an implanted device that continuously removes excess fluid from the abdomen, potentially improving patient quality of life by reducing the need for frequent hospital visits for paracentesis. The study will assess the medical-economic impact of this device over one year, focusing on patients both awaiting liver transplantation and those who are not. Participants will be monitored for quality-adjusted life years (QALYs) generated and complications related to their treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with refractory ascites who have undergone at least five paracentesis procedures in the last three months and have a life expectancy of at least six months.
Not a fit: Patients with severe liver dysfunction, active infections, or contraindications to the Alfapump® device will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with refractory ascites by reducing hospital visits and complications.
How similar studies have performed: While the Alfapump® device represents a novel approach, similar studies have shown promising results in improving outcomes for patients with refractory ascites.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amiens and 9 other locations
- Amiens-Picardie University Hospital — Amiens, France (RECRUITING)
- Chu Angers — Angers, France (RECRUITING)
- Jean MINJOZ Univesity Hospital — Besançon, France (RECRUITING)
- Haut-Lévêque Hospital — Bordeaux, France (NOT_YET_RECRUITING)
- Beaujon Hospital — Clichy, France (RECRUITING)
- Grenoble University Hospital — Grenoble, France (RECRUITING)
- LA PITIE SALPETRIERE Univesity Hospital — Paris, France (RECRUITING)
- Chu Poitiers — Poitiers, France (NOT_YET_RECRUITING)
- Chu Pontchaillou — Rennes, France (RECRUITING)
- Toulouse University Hospital — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Marie-Noelle HILLERET, MD — University Hospital, Grenoble
- Study coordinator: Sandra DAVID-TCHOUDA, MD
- Email: sdavidtchouda@chu-grenoble.fr
- Phone: +33 476 76 71 86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ascites, Paracentesis, Cirrhosis, refractory ascite, pump system