Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Apr 12, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Alfapump® for patients with a condition known as refractory ascites, which is a buildup of fluid in the abdomen that doesn’t respond well to standard treatments. The goal is to see if using the Alfapump® can improve patients' quality of life and reduce healthcare costs by decreasing the need for repeated procedures called paracentesis, where fluid is drained from the abdomen. The study is looking at two groups of patients: those waiting for a liver transplant and those who are not.

To be eligible for this trial, participants must have had at least five paracentesis procedures in the past three months and should expect to live at least six more months. They also need to be able to give informed consent and have certain medical conditions ruled out, like infections or severe liver disease. If you join the trial, you can expect to receive the Alfapump® device, and researchers will monitor your health and how well the device works over the next year. This is an exciting opportunity to potentially improve treatment options for patients with difficult-to-treat ascites.

Gender

ALL

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.