Continuous low flow ascites drainage through the urinary bladder via the Alfapump system in palliative patients with malignant ascites.

BACKGROUND: Malignant Ascites (MA) is a therapeutic dilemma significantly impairing patients' quality of life (QoL). The Sequana Medical alfapump System (AP), a subcutaneous, externally rechargeable, implantable device, continually draining ascites via the urinary bladder, has been well established in liver cirrhosis, but not yet in MA. The AP-system was evaluated in cancer patients in reducing the need for large volume paracentesis (LVP). METHODS: A retrospective multicentre evaluation of all eligible patients who received an AP for MA-palliation was performed. AP was evaluated for its ability to reduce LVP and cross-correlated with adverse events (AE), survival and retrospective physician-reported QoL. RESULTS: Seventeen patients with median age of 63 years (range: 18-81), 70.6% female, across 7 primary tumour types were analysed. Median duration of AP-implantation was 60 min (range: 30-270) and median post-implantation hospital stay: 4 days (range: 2-24). Twelve protocol-defined AE occurred in 5 patients (29.4%): 4 kidney failures, 4 pump/catheter-related blockages, 3 infections/peritonitis and 1 wound dehiscence. Median ascitic volume (AV) pumped daily was 303.6 ml/day (range:5.6-989.3) and median total AV drained was 28 L (range: 1-638.6). Median patient post-AP-survival was 111 days (range:10-715) and median pump survival was 89 days (range: 0-715). Median number of paracenteses was 4 (range: 1-15) per patient pre-implant versus 1 (range: 0-1) post-implant (p = 0.005). 71% of patients were reported to have an improvement of at least one physician reported QoL-parameters. CONCLUSIONS: AP appears to be effective in palliating patients with MA by an acceptable morbidity profile. Its broader implementation in oncology services should be further explored. TRIAL REGISTRATION: NCT03200106; June 27, 2017.

Quality of life improves after palliative placement of percutaneous tunneled drainage catheter for refractory ascites in prospective study of patients with end-stage cancer.

OBJECTIVE: Percutaneous tunneled drainage catheter (PTDC) placement is a palliative alternative to serial paracenteses in patients with end-stage cancer and refractory ascites. The impact of PTDC on quality of life (QoL) and long-term outcomes has not been prospectively described. The objective was to evaluate changes in QoL after PTDC. METHOD: Eligible adult patients with end-stage cancer undergoing PTDC placement for refractory ascites completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and McGill Quality of Life instruments before PTDC placement and at 2 to 7 days and 2 to 4 weeks after PTDC. Catheter function, complications, and laboratory values were assessed. Analysis of QoL data was evaluated with a stratified Wilcoxon signed-rank test. RESULT: Fifty patients enrolled. Survey completion ranged from 65% to 100% (median 88%) across timepoints. All patients had a Tenckhoff catheter, with 98% technical success. Median survival after PTDC was 38 days (95% confidence interval = 32, 57 days). European Organization for Research and Treatment of Cancer scores showed improvement in global QoL (p = 0.03) at 1 week postprocedure (PP). Significant symptom improvement was reported for fatigue, nausea/vomiting, pain, dyspnea, insomnia, and appetite at 1 week PP and was sustained at 3 weeks PP for dyspnea (p < 0.01), insomnia (p < 0.01), and appetite loss (p = 0.03). McGill Quality of Life demonstrated overall QoL improvement at 1 (p = 0.03) and 3 weeks (p = 0.04) PP. Decline in sodium and albumin values pre- and post-PTDC slowed significantly (albumin slope -0.43 to -0.26, p = 0.055; sodium slope -2.50 to 1.31, p = 0.04). Creatinine values increased at an accelerated pace post-PTDC (0.040 to 0.21, p < 0.01). Thirty-eight catheter-related complications occurred in 24 of 45 patients (53%). SIGNIFICANCE OF RESULTS: QoL and symptoms improved after PTDC placement for refractory ascites in patients with end-stage malignancy. Decline in sodium and albumin values slowed postplacement. This study supports the use of a PTDC for palliation of refractory ascites in cancer patients.

Patients' perspectives towards malignant ascites: results of a prospective observational trial regarding expectations, characteristics and quality of life-a study of the North-Eastern-German Society of Gynecological Oncology.

PURPOSE: Malignant ascites (MA) is a frequent and common symptom in (gyneco-) oncological patients. The present trial evaluated and assessed patients' characteristics, clinical features and the possible influence of MA on QoL measurements. METHODS: A prospective observational trial was conducted from Oct 2013 until Nov 2016. Therefore an interdisciplinary questionnaire was developed. Overall 250 patients with histological confirmed MA were included with different cancer entities (gynecological, gastrointestinal). The correlation of MA caused symptoms and QoL measurements was assessed using Kendall's tau b. Multivariable logistic regression models were applied to analyze the risks of symptoms or severe limitation in daily activities. RESULTS: 125 questionnaires could be analyzed. The majority of patients with MA had diagnosis of ovarian cancer (68.8%) and were under current cancer treatment (57.6%), mostly chemotherapy. Over 50% reported abdominal tension as major symptom, around 56% of the patients had MA when cancer was firstly diagnosed. Regression analysis showed that patients with MA above 2l were significantly more likely to be harmed in everyday activities. However, the age, gender, type of malignancy and the current treatment (chemotherapy vs. no chemotherapy) had no significant influence. CONCLUSION: MA has a significantly impact on QoL measurements in cancer patients and might influence everyday activities including basic needs like eating, walking and body care. There is a high need for more information and education of patients with MA.

Management of ascites and hepatorenal syndrome.

Ascites represents the most common decompensating event in patients with liver cirrhosis. The appearance of ascites is strongly related to portal hypertension, which leads to splanchnic arterial vasodilation, reduction of the effective circulating volume, activation of endogenous vasoconstrictor systems, and avid sodium and water retention in the kidneys. Bacterial translocation further worsens hemodynamic alterations of patients with cirrhosis and ascites. The first-line treatment of uncomplicated ascites is a moderate sodium-restricted diet combined with diuretic treatment. In patients who develop refractory ascites, paracentesis plus albumin represents the most feasible option. Transjugular intrahepatic portosystemic shunt placement is a good alternative for selected patients. Other treatments such as vasoconstrictors and automated low-flow pumps are two potential options still under investigations. Ascites is associated with a high risk of developing further complications of cirrhosis such as dilutional hyponatremia, spontaneous bacterial peritonitis and/or other bacterial infections and acute kidney injury (AKI). Hepatorenal syndrome (HRS) is the most life-threatening type of AKI in patients with cirrhosis. The most appropriate medical treatment in patients with AKI-HRS is the administration of vasoconstrictors plus albumin. Finally, ascites impairs both the quality of life and survival in patients with cirrhosis. Thus, all patients with ascites should be evaluated for the eligibility for liver transplantation. The aim of this article is to review the management of patients with cirrhosis, ascites and HRS.

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.

Behavior and clinical impact of ascites after living donor liver transplantation: risk factors associated with massive ascites.

BACKGROUND: Massive ascites after living donor liver transplantation (LDLT), defined as small-for-size graft syndrome, is a risk factor for a poor prognosis. Few studies have reported factors associated with ascites and the relevant outcome after LDLT. METHODS: Data from 413 adult patients that underwent LDLT were retrospectively analyzed. RESULTS: Recipient age, preoperative albumin level, Child-Pugh score, preoperative ascites, graft volume, intraoperative blood loss, and duration of warm ischemic time and the anhepatic phase were significantly associated with the total amount of ascites between postoperative day (POD) 1 and POD14. Multivariate analysis identified preoperative ascites, intraoperative blood loss, and duration of anhepatic phase as factors. Massive ascites (ascitic fluid discharge >1,000 ml/day on POD14 after LDLT) occurred in 200 (48.4%) patients, and mild ascites occurred in the remaining 213 patients. Daily changes in the ascites volume differed between the two groups. Nevertheless, massive ascites itself did not have a critical impact on the patient short- and long-term outcomes when properly managed with rigorous diuretics and albumin administration. CONCLUSION: Massive ascites is frequent after LDLT; however, the impact of it could be minimized with an appropriate management.

Patient experience of non-malignant ascites and its treatment: a qualitative study.

BACKGROUND: Ascites is an accumulation of serous fluid in the abdominal cavity. It can be caused by both malignant and non-malignant conditions and produces distressing symptoms. There have been no qualitative studies looking at the experiences of patients with non-malignant ascites. AIMS: To explore the experiences of patients living with non-malignant ascites and its management. Also, to explore the views of these patients about services available to them. METHOD: Phenomenological qualitative research study using digitally recorded semi-structured interviews. SETTING AND PARTICIPANTS: Six adult patients with non-malignant ascites who were receiving paracentesis to manage their symptoms in an acute hospital day unit. RESULTS: Participants experienced a wide variety of physical symptoms. They discussed how the ascites impacted on their social lives. They had views on diuretics, low sodium diet and paracentesis as methods of symptom management. Participants' confidence in staff performing paracentesis was a common finding, particularly as ultrasound was rarely used. While only some were suitable for liver transplant, all discussed their future care needs. CONCLUSION: Participants' experiences of non-malignant ascites are that it has a considerable effect on their quality of life. Patients like the system of day case admission for drainage, but question whether this is sustainable. Advanced practitioners can successfully provide a paracentesis service for these patients in hospitals and potentially this is transferable to hospices. Patients seemed happy to consider the option of semi-permanent drains and pumps as methods of managing ascites.

Reliability and Validity of the Chinese Version of FACIT-AI, a New Tool for Assessing Quality of Life in Patients with Malignant Ascites.

OBJECTIVE: The study objective was to determine the reliability and validity of the Chinese version of the Functional Assessment of Chronic Illness Therapy - Ascites Index (FACIT-AI). METHODS: A forward-backward translation procedure was adopted to develop the Chinese version of the FACIT-AI, which was tested in 69 patients with malignant ascites. Cronbach's α, split-half reliability, and test-retest reliability were used to assess the reliability of the scale. The content validity index was used to assess the content validity, while factor analysis was used for construct validity and correlation analysis was used for criterion validity. RESULTS: The Cronbach's α was 0.772 for the total scale, and the split-half reliability was 0.693. The test-retest correlation was 0.972. The content validity index for the scale was 0.8-1.0. Four factors were extracted by factor analysis, and these contributed 63.51% of the total variance. Item-total correlations ranged from 0.591 to 0.897, and these were correlated with visual analog scale scores (correlation coefficient, 0.889; P<0.01). CONCLUSIONS: The Chinese version of the FACIT-AI has good reliability and validity and can be used as a tool to measure quality of life in Chinese patients with malignant ascites.

Factors related to quality of life in patients with cirrhosis and ascites: relevance of serum sodium concentration and leg edema.

BACKGROUND & AIMS: Hyponatremia is common in patients with cirrhosis and ascites and is associated with significant neurological disturbances. However, its potential effect on health-related quality of life (HRQL) in cirrhosis has not been investigated. We aimed at assessing the relationship between serum sodium concentration and other clinical and analytical parameters on HRQL in cirrhosis with ascites. METHODS: A total of 523 patients with cirrhosis and ascites were prospectively investigated. Assessment of HRQL was done with the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire, which is divided into 8 domains, summarized in two components: physical component score (PCS) and mental component score (MCS). Demographic, clinical, and analytical data at baseline were analyzed for their relationship with HRQL. RESULTS: In multivariate analysis, independent predictive factors associated with an impaired PCS were non-alcoholic etiology of cirrhosis, severe ascites, history of previous episodes of hepatic encephalopathy and falls, presence of leg edema, and low serum sodium concentration. With respect to MCS, only two factors were associated with the independent predictive value: low serum sodium concentration and treatment with lactulose or lactitol. In both components, the scores decreased in parallel with the reduction in serum sodium concentration. Variables more commonly associated with the independent predictive value in the individual 8 domains of PCS and MCS were presence of leg edema and serum sodium concentration, 7 and 6 domains, respectively. CONCLUSIONS: Serum sodium concentration and presence of leg edema are major factors of the impaired HRQL in patients with cirrhosis and ascites.

Quality of life in cirrhosis is related to potentially treatable factors.

OBJECTIVE: Improvement of prognosis and availability of diverse therapeutic options for complications of advanced liver disease highlight the importance of health-related quality of life (HRQOL) in cirrhosis. The aim of this study was to identify factors that influence HRQOL and may be potentially treatable in patients with cirrhosis. METHODS: HRQOL was measured in 212 outpatients with cirrhosis using a generic questionnaire (Medical Outcomes Study Form, SF-36) and a liver-specific questionnaire (Chronic Liver Disease Questionnaire, CLDQ). All patients underwent a systematic clinical and neuropsychological assessment. Independent factors associated with poor HRQOL were identified by multiple linear regression. RESULTS: HRQOL scores exhibited by patients were: global CLDQ: 4.8+/-1.2; Physical Component Score of SF-36: 38.5+/-10.7; Mental Component Score of SF-36: 45.3+/-14.3. The independent variables for global CLDQ were female sex, nonalcoholic etiology, current ascites, and a decrease in albumin (R = 0.22). For Physical Component Score of SF-36, the independent variables were prior hepatic encephalopathy, current ascites, and a decrease in hemoglobin (R = 0.22). For Mental Component Score of SF-36, the independent variables were nonalcoholic etiology, the Grooved Pegboard test, and a decrease in hemoglobin (R = 0.14). CONCLUSION: Several clinical variables, potentially treatable, may alter particular aspects of HRQOL. Correction of ascites, hypoalbuminemia, minimal hepatic encephalopathy, and anemia may cause a positive impact on HRQOL of patients with cirrhosis.

[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.

Quality of life in refractory ascites: transjugular intrahepatic portal-systemic shunting versus medical therapy.

Uncontrolled studies suggest that transjugular intrahepatic portal-systemic shunting (TIPS) may improve quality of life in patients with refractory ascites. We hypothesized that any improvement of quality of life in patients with TIPS would be matched in controls due to the competing effects of improved ascites and worsened hepatic encephalopathy. Thus, an analysis of quality of life was performed using original data from the North American Study for the Treatment of Refractory Ascites, a multicenter trial of 109 patients randomized to TIPS or repeated large volume paracentesis (LVP) for refractory ascites. Short form 36 (SF-36) surveys were completed at baseline and at 6- and 12-month follow-up. Variables analyzed were: randomization group, number of LVP performed, cumulative volume from LVP, shortness of breath, abdominal distention, abdominal pain, diuretic usage, confusion, hospitalizations, and emergency room visits. Outcomes were changes in physical component scale (PCS) and mental component scale (MCS) of SF-36 results. We constructed multivariable, mixed effects models, including randomization group and baseline MCS and PCS. Changes in PCS and MCS from baseline were similar between the two randomization groups. In multivariate analysis, PCS improvement was associated with lack of confusion, improved ascites, and lack of hospitalizations, but not directly with randomization group. Improvement in MCS was associated with randomization to TIPS and lack of confusion. In conclusion, patients with refractory ascites randomized to TIPS or repeated LVP had similar changes in quality of life. Competing effects of hepatic encephalopathy, requirement for repeated LVP, and need for hospitalizations explain similar changes in quality of life between the two groups.

Locoregional immunotherapy of malignant ascites by intraperitoneal administration of OK-432 plus IL-2 in gastric cancer patients.

The clinical efficacy of intraperitoneal administration of OK-432 plus interleukin-2 (IL-2) for treating malignant ascites was evaluated in gastric cancer patients. Ten KE of OK-432 and 200,000 Jurkat units of IL-2 were intraperitoneally administered in tandem in the order given on alternate days at paracentesis. Of the 22 evaluable patients, 18 (81%) developed complete or partial responses, showing a cytologic disappearance of cancer cells and decrease of ascites. More than 50% of the patients obtained positive responses within 2 weeks after the initial administration of the drugs. Improvements of performance status and clinical symptoms such as abdominal fullness, followed by restoration of oral food intake and prolongation of survival time were observed in responders treated with OK-432 plus IL-2. Flow cytometric analysis demonstrated a predominant increase of the CD3+CD4+ cells, especially of the CD4+CD45RA- subset in the peritoneal cavity of the responders. Cytotoxicity assay after negative selection of the CD4+ cells with the antibody and complement revealed that the CD4+ subset possessed cytotoxic activity against autologous tumor cells. The results suggest that intraperitoneal administration of OK-432 plus IL-2 may not be only a practical but also an effective protocol for treating malignant ascites in gastric cancer patients.