Evaluation of the Alfapump® device for treating refractory ascites in cirrhotic patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amiens-Picardie University Hospital
  Amiens, France Recruiting
• Chu Angers
  Angers, France Recruiting
• Jean MINJOZ Univesity Hospital
  Besançon, France Recruiting
• Beaujon Hospital
  Clichy, France Recruiting
• Grenoble University Hospital
  Grenoble, France Recruiting
• LA PITIE SALPETRIERE Univesity Hospital
  Paris, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.