About the project
Liver disease related deaths in England have increased by >250% since 1971. In 2018, liver disease accounted for >10% of deaths in those aged 35-49 years, greater than deaths from suicide/heart disease/breast cancer. Nationally, the COVID pandemic resulted in a 20% increase in all cause alcohol-related deaths (mostly related to liver disease) in 2020.
Ascites is the most frequent cirrhosis complication, often requiring hospitalisation, and leads to a debilitating condition called refractory ascites, associated with intense pain and breathlessness. Without a liver transplant, refractory ascites has an average life expectancy of 6-12 months. However, most patients with advanced cirrhosis are not candidates for liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS) or the Automated Low Flow Ascites (ALFA) pump. The most common intervention for refractory ascites is hospitalisation every 10-14 days for palliative large volume paracentesis (LVP). This involves an abdominal drain insertion for up to six hours, removal of 5-15 litres of fluid and administration of intravenous human albumin solution.
Our aim is to optimise palliative management in often vulnerable individuals with refractory ascites due to advanced cirrhosis, thereby resulting in better health-related quality of life (HRQoL).
This study will compare insertion of a palliative tunnelled long-term abdominal drain (LTAD) (Group 1 intervention) to standard of care (Group 2 intervention) large volume paracentesis (LVP) in the management of refractory ascites. Patients will be randomised into one of the 2 groups, then followed-up with fortnightly home visits for 3 months. They will have routine bloods taken and will be asked to complete various questionnaires at the visits. Informal caregivers will also be asked to complete a questionnaire monthly.
The study aims to recruit 310 across 35 sites in England and Scotland. In addition, 30 patients, 20 informal caregivers and 20 Healthcare Professionals will be invited for an optional qualitative interview by SHORE-C (University of Sussex) to give their perceptions/perspectives of LTAD and LVP.
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