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. Lay summary: The alfapump® moves abdominal fluid into the bladder from where it is then removed by urination. Compared with standard treatment, the alfapump reduces the need for large volume paracentesis (manual fluid removal by needle) in patients with medically untreatable ascites. This can improve life quality for these patients. www.clinicaltrials.gov#NCT01528410.

中文翻译：

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Alfapump® 系统与难治性腹水的大容量穿刺术：一项多中心随机对照研究

背景和目的 难治性腹水 (RA) 患者需要反复进行大量腹腔穿刺术 (LVP)，这涉及频繁的医院就诊并且与较差的生活质量相关。本研究评估了自动低流量泵 (alfapump® [AP]) 与 LVP 护理标准 [SoC] 的安全性和有效性。方法 在七个中心进行了一项随机对照试验，对患者进行了为期六个月的观察。主要结果是首次 LVP 的时间。次要结果包括穿刺要求、安全性、健康相关生活质量 (HRQoL) 和存活率。在三个月后的一项子研究中评估了营养、血流动力学和肾损伤生物标志物。结果 60 名患者被随机分组​​并分析了 58 名患者（27 名 AP，31 名 SoC，平均年龄 61.9 岁，平均 MELD 11.7）。18 名患者包括在子研究中。AP 和 SoC 的生存率相似。结论 AP 系统可有效减少肝硬化 RA 患者对腹腔穿刺的需求并提高生活质量。尽管 AP 组 SAE 的频率（以及推断住院）显着更高，但它们通常是有限的，并且不会影响生存。小结：alfapump® 将腹液移入膀胱，然后通过排尿排出。与标准治疗相比，alfapump 减少了对医学上无法治疗的腹水患者进行大容量腹腔穿刺术（通过针头手动取出液体）的需要。这可以改善这些患者的生活质量。www.clinicaltrials.gov#NCT01528410。结论 AP 系统可有效减少肝硬化 RA 患者对腹腔穿刺的需求并提高生活质量。尽管 AP 组 SAE 的频率（以及推断住院）显着更高，但它们通常是有限的，并且不会影响生存。小结：alfapump® 将腹液移入膀胱，然后通过排尿排出。与标准治疗相比，alfapump 减少了对医学上无法治疗的腹水患者进行大容量腹腔穿刺术（通过针头手动取出液体）的需要。这可以改善这些患者的生活质量。www.clinicaltrials.gov#NCT01528410。结论 AP 系统可有效减少肝硬化 RA 患者对腹腔穿刺的需求并提高生活质量。尽管 AP 组 SAE 的频率（以及推断住院）显着更高，但它们通常是有限的，并且不会影响生存。小结：alfapump® 将腹液移入膀胱，然后通过排尿排出。与标准治疗相比，alfapump 减少了对医学上无法治疗的腹水患者进行大容量腹腔穿刺术（通过针头手动取出液体）的需要。这可以改善这些患者的生活质量。www.clinicaltrials.gov#NCT01528410。小结：alfapump® 将腹液移入膀胱，然后通过排尿排出。与标准治疗相比，alfapump 减少了对医学上无法治疗的腹水患者进行大容量腹腔穿刺术（通过针头手动取出液体）的需要。这可以改善这些患者的生活质量。www.clinicaltrials.gov#NCT01528410。小结：alfapump® 将腹液移入膀胱，然后通过排尿排出。与标准治疗相比，alfapump 减少了对医学上无法治疗的腹水患者进行大容量腹腔穿刺术（通过针头手动取出液体）的需要。这可以改善这些患者的生活质量。www.clinicaltrials.gov#NCT01528410。