ALFApump System Versus Standard of Care in Ascites Treatment

Study Overview
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Brief Summary
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This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.

Official Title
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ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.

Conditions
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Refractory or Recurrent Ascites

Intervention / Treatment
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* Device: ALFApump removal of ascites
* Procedure: Large volume paracentesis for removal of ascites


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and non-pregnant females (determined by serum pregnancy test) ≥ 18 years of age. Women of childbearing age must be prepared to use at least 1 effective (≤ 1% failure rate) method of contraception during the course of the study Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria Presenting refractory or recurrent ascites and requiring periodic large volume paracentesis (large volume defined as > 5 L to accord with teh clinical guidance of EASL, European Association for the Study of the Liver, which recommends withdrawal of 5 L should precipitate administration of albumin). Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device Exclusion Criteria: Gastrointestinal haemorrhage over the last 7 days Renal failure defined as serum creatinine higher than or equal to 2 mg/dl Severe coagulopathy defined as prothrombin time greater than 40% more than upper limit of Normal (as determined locally). Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery Clinical Evidence of recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks. Clinical evidence of recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks. Clinical evidence of loculated ascites. Advanced hepatocarcinoma, defined as one which exceeds Milan criteria. Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device. Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to, cardiac pacemaker or cardioverter defibrillator. Pregnant females or females anticipating pregnancy during study period Patients currently enrolled in another interventional clinical study Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure) Known presence of human immunodeficiency virus (HIV) Immuno-modulatory treatment (including azothioprine, methotrexate, anti-TNF therapies) used within last 4 months Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years BMI > 40 presenting a risk for surgery and tunneled lines Patients with contraindications for general anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a single center, open-label trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALFApump removal of ascites<br>Removal of ascites | Device: ALFApump removal of ascites<br>* Implanted ALFApump, removing produced ascites according to programmed schedule<br>* Other names: ALFApump (Automated Low Flow Ascites pump);|
| Active Comparator: Large volume paracentesis for removal of ascites<br>Removal of ascites | Procedure: Large volume paracentesis for removal of ascites<br>* Large volume paracentesis - standard of care, removing ascites according to patient need<br>* Other names: Extraction of fluid from the abdominal cavity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paracentesis free survival | Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis > 5 litres | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system | Cirrhosis-related complications | 6 months | 
| Quality of Life |  | 6 months | 
| Body weight |  | 6 months | 
| Nutritional profile |  | 6 months | 
| Resource utilisation |  | 6 months | 
| Survival |  | 6 months | 
| Assess the need for repeat evacuation paracentesis |  | 6 months |