Bureau, C;
Adebayo, D;
Chalret de Rieu, M;
Elkrief, L;
Valla, D;
Peck-Radosavljevic, M;
McCune, A;
... Jalan, R; + view all
(2017)
Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study.
Journal of Hepatology
, 67
(5)
pp. 940-949.
10.1016/j.jhep.2017.06.010.
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Jalan_alfapump System vs. Large Volume Paracentesis for Refractory Ascites Accepted.pdf - Accepted Version Download (1MB) | Preview |
Abstract
BACKGROUND AND AIMS: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with a poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump® [AP]) compared with LVP standard of care [SoC]. METHODS: A randomized controlled trial, in seven centers, with six month patient observation was conducted. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival. Nutrition, hemodynamics, and renal injury biomarkers were assessed in a sub-study at three months. RESULTS: Sixty patients were randomized and 58 were analyzed (27 AP, 31 SoC, mean age 61.9years, mean MELD 11.7). Eighteen patients were included in the sub-study. Compared with SoC, median time to first LVP was not reached after six months in the AP group, meaning a significant reduction in LVP requirement for the AP patients (AP, median not reached; SoC, 15.0days (HR 0.13; 95%CI 13.0-22.0; p<0.001), and AP patients also showed significantly improved Chronic Liver Disease Questionnaire (CLDQ) scores compared with SoC patients (p<0.05 between treatment arms). Improvements in nutritional parameters were observed for hand-grip strength (p=0.044) and body mass index (p<0.001) in the sub-study. Compared with SoC, more AP patients reported adverse events (AEs; 96.3% vs. 77.4%, p=0.057) and serious AEs (85.2 vs. 45.2%, p=0.002). AEs consisted predominantly of acute kidney injury in the immediate post-operative period, and re-intervention for pump related issues, and were treatable in most cases. Survival was similar in AP and SoC. CONCLUSIONS: The AP system is effective for reducing the need for paracentesis and improving quality of life in cirrhotic patients with RA. Although the frequency of SAEs (and by inference hospitalizations) was significantly higher in the AP group, they were generally limited and did not impact survival.
| Type: | Article |
|---|---|
| Title: | Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study |
| Location: | Netherlands |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1016/j.jhep.2017.06.010 |
| Publisher version: | http://doi.org/10.1016/j.jhep.2017.06.010 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions. - Please note that corrigenda have been issued: i) Journal of Hepatology, Volume 68 (3), p.630; DOI: 10.1016/j.jhep.2017.12.017 and ii) DOI https://doi.org/10.1016/j.jhep.2019.11.023, dated 9 January 2020. |
| Keywords: | Liver cirrhosis, Paracentesis, Refractory ascites |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inst for Liver and Digestive Hlth |
| URI: | https://discovery.ucl.ac.uk/id/eprint/1555241 |
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