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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALFApump removal of ascites | Experimental | Removal of ascites |
|
| Large volume paracentesis for removal of ascites | Active Comparator | Removal of ascites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALFApump removal of ascites | Device | Implanted ALFApump, removing produced ascites according to programmed schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Paracentesis free survival | Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis > 5 litres | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajiv Jalan, Professor | UCL Institute of Hepatology, Royal Free Hospital, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna General Hospital and Medical School, AKH | Vienna | Austria | ||||
| Hopital Beaujon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29460201 | Derived | Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump(R) 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. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19. | |
| 28645737 |
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| ID | Term |
|---|---|
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study will be a single center, open-label trial.
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| Large volume paracentesis for removal of ascites | Procedure | Large volume paracentesis - standard of care, removing ascites according to patient need |
|
|
| Body weight | 6 months |
| Nutritional profile | 6 months |
| Resource utilisation | 6 months |
| Survival | 6 months |
| Assess the need for repeat evacuation paracentesis | 6 months |
| Clichy, Paris |
| France |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France |
| Azienda Ospedaliera di Padova | Padova | Italy |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Bristol Royal Infirmary | Bristol | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Derived |
| Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump(R) system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21. |