Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2018
Patients with refractory ascites treated with alfapump® 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.
Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.
Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Who cites it
18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Patient-reported and caregiver-reported outcomes in refractory ascites secondary to cirrhosis: A systematic review and meta-analysis.Hepatology communications · 2026Pooled it
- Treatment for ascites in adults with decompensated liver cirrhosis: a network meta-analysis.The Cochrane database of systematic reviews · 2020Pooled it
- Symptom prevalence and quality of life of patients with end-stage liver disease: A systematic review and meta-analysis.Palliative medicine · 2019Pooled it
- HEALTH-RELATED QUALITY OF LIFE IN CHRONIC LIVER DISEASE: CLINICAL BURDEN, DETERMINANTS, AND IMPLICATIONS FOR PATIENT-CENTERED CARE.Arquivos de gastroenterologia · 2026Review
- Using the Alfapump® to control ascites enabling elective umbilical hernia repair: A case report.Hernia : the journal of hernias and abdominal wall surgery · 2025Article
- Palliative care in terminally ill advanced chronic liver disease patients.Wiener klinische Wochenschrift · 2025Review
- Drainage of ascites in cirrhosis.World journal of hepatology · 2024Review
- Recent developments in the management of ascites in cirrhosis.United European gastroenterology journal · 2024Review
- A soft, bioinspired artificial lymphatic system for interactive ascites transfer.Bioengineering & translational medicine · 2023Article
- Innovative approaches to the management of ascites in cirrhosis.JHEP reports : innovation in hepatology · 2023Review
- Management of refractory ascites.Clinical and molecular hepatology · 2023Review
- AlfapumpWorld journal of hepatology · 2022Review
- Reply.Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society · 2020Article
- Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump.Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society · 2020Article
- Palliative care in liver disease: what does good look like?Frontline gastroenterology · 2020Review
- Nutritional status in patients with liver cirrhosis.Clinical and experimental hepatology · 2019Article
- Article
- Palliative Care for Patients with End-Stage Liver Disease.Journal of clinical and experimental hepatologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 10 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRefractory ascites (RA) is a complication of cirrhosis which is treated with large volume paracentesis (LVP) as the standard of care. Alfapump® system is a fully implantable pump system which reduces the need for LVP. The aim was to assess health-related quality of life (HRQL) in patients treated with alfapump® versus LVP.
methodsThe data were collected in a multicenter open-label randomized controlled trial (clinicaltrials.gov #NCT01528410). Subjects with cirrhosis Child-Pugh class B or C accompanied by RA were randomized to receive alfapump® or LVP. The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment.
resultsOf 60 subjects randomized, HRQL data were available for 58 (N = 27 received alfapump® and N = 31 received LVP only). At baseline, no differences were seen between the treatment arms (all p > 0.05): age 61.9 ± 8.4, 79.3% male, MELD scores 11.7 ± 3.3, 85.2% Child-Pugh class B, 70.7% had alcoholic cirrhosis. The mean number of LVP events/subject was lower in alfapump® than LVP (1.1 vs. 8.6, p < 0.001). The HRQL scores showed a moderate improvement from the baseline levels in subjects treated with alfapump® (p < 0.05 for abdominal and activity scores of CLDQ) but not with LVP (all one-sided p > 0.05) in the first 3 months. Multivariate analysis showed that treatment with alfapump® was independently associated with better HRQL at 3 months (total CLDQ score: beta = 0.67 ± 0.33, p = 0.05).
conclusionAs compared to LVP, the use of alfapump® system is associated with both a reduction in the number of LVP events and improvement of health-related quality of life.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.