Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study.

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.

Conformity of behaviors among medical students: impact on performance of knee arthrocentesis in simulation.

Although the development of collaborative relationships is considered a requirement for medical education, the functioning of these relationships may be impaired by a well-documented social-psychological phenomenon known as group conformity. The authors hypothesized that students would insert a needle into an incorrect location relative to the patella when performing a knee arthrocentesis if they believed that their peers had also inserted a needle in the same incorrect location. This was a randomized controlled study conducted in 2011 with 60 medical students (24 male; 40.0 %) who were randomly assigned to either using a knee model that had a skin with holes left by peers inserting needles in the wrong location, or a knee with no marks in the skin. Each student's aspiration site was measured with a fibreglass ruler to determine whether it was correctly located within the superior third, 1 cm medial to the patella. The researchers determined that students who used the marked skin were more likely to insert the needle in the incorrect location compared to those who used the clean skin (n = 31, 86.11 vs. n = 14, 58.33 %), Fisher's exact test (1) = 5.93, p < 0.05, Cramer's ϕ = 0.31. This study demonstrates incorrect performance of the knee arthrocentesis procedure in simulation when students use a damaged model, which may be due to conformity. It suggests that further research on the impact of conformity in medical education is warranted.

[Methods of symptom control in malignant ascites]. / Maligner Ascites--Möglichkeiten der Symptomkontrolle.

Ascites remains a challenge in many patients with advanced cancers in palliative care. Although paracentesis, diuretics and shunting are the commonly used procedures, the evidence is weak. A fast but temporary effect is achieved on symptom relief by paracentesis. Some inherent risks have to be taken into account. On the basis of a case report, different attempts to control malignant ascites are discussed. The report of a young woman with relapsing ovarian cancer and recurrent ascites is presented including the management of symptomatic malignant ascites.