Abstract
BackgroundUK deaths due to chronic liver diseases such as cirrhosis have quadrupled over the last 40 years, making this condition now the third most common cause of premature death. Most patients with advanced cirrhosis (end-stage liver disease [ESLD]) develop ascites. This is often managed with diuretics, but if refractory, then the fluid is drained from the peritoneal cavity every 10–14 days by large volume paracentesis (LVP), a procedure requiring hospital admissions. As the life expectancy of patients with ESLD and refractory ascites (if ineligible for liver transplantation) is on average ≤ 6 months, frequent hospital visits are inappropriate from a palliative perspective. One alternative is long-term abdominal drains (LTADs), used successfully in patients whose ascites is due to malignancy. Although inserted in hospital, these drains allow ascites management outside of a hospital setting. LTADs have not been formally evaluated in patients with refractory ascites due to ESLD.Methods/designDue to uncertainty about appropriate outcome measures and whether patients with ESLD would wish or be able to participate in a study, a feasibility randomised controlled trial (RCT) was designed. Patients were consulted on trial design. We plan to recruit 48 patients with refractory ascites and randomise them (1:1) to either (1) LTAD or (2) current standard of care (LVP) for 12 weeks. Outcomes of interest include acceptability of the LTAD to patients, carers and healthcare professionals as well as recruitment and retention rates. The Integrated Palliative care Outcome Scale, the Short Form Liver Disease Quality of Life questionnaire, the EuroQol 5 dimensions instrument and carer-reported (Zarit Burden Interview) outcomes will also be assessed. Preliminary data on cost-effectiveness will be collected, and patients and healthcare professionals will be interviewed about their experience of the trial with a view to identifying barriers to recruitment.DiscussionLTADs could potentially improve end-of-life care in patients with refractory ascites due to ESLD by improving symptom control, reducing hospital visits and enabling some self-management. Our trial is designed to see if such patients can be recruited, as well as to inform the design of a subsequent definitive trial.Trial registrationISRCTN, ISRCTN30697116. Registered on 7 October 2015.
Highlights
UK deaths due to chronic liver diseases such as cirrhosis have quadrupled over the last 40 years, making this condition the third most common cause of premature death
The impetus for the REduced Drainage Utreatable Cirrhosis (REDUCe) trial was driven by our concerns that patients with End-stage liver disease (ESLD) receive suboptimal end-of-life care compared to those with other terminal conditions
Most individuals with ESLD almost always die in hospital [6] while receiving end-of-life care, even though in many cases palliative care provided within the community would be more appropriate and compassionate
Summary
UK deaths due to chronic liver diseases such as cirrhosis have quadrupled over the last 40 years, making this condition the third most common cause of premature death. Most patients with advanced cirrhosis (end-stage liver disease [ESLD]) develop ascites. This is often managed with diuretics, but if refractory, the fluid is drained from the peritoneal cavity every 10–14 days by large volume paracentesis (LVP), a procedure requiring hospital admissions. The most common palliative management for refractory ascites due to ESLD is large volume paracentesis (LVP), performed every 10–14 days [3]. This involves a costly 24–48 h hospital admission, insertion of a temporary abdominal drain and removal of up to 15 L of ascitic fluid over 4–6 h. Individuals with refractory ascites often have contraindications to alternative invasive procedures such as the transjugular intrahepatic portosystemic shunt (TIPS) [10] and/or the automated low-flow ascites (ALFA) pump [11]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
