REDUCe 2 Study V1.0
Research type
Research Study
Full title
Palliative Long-term Abdominal Drains Versus Repeated Drainage in Untreatable Ascites Due to Advanced Cirrhosis: A Randomised Controlled Trial (REDUCe 2 Study)
IRAS ID
314073
Contact name
Sumita Verma
Contact email
Sponsor organisation
University of Sussex
Duration of Study in the UK
3 years, 11 months, days
Research summary
Our aim is to see if palliative long-term abdominal drains (LTADs) result in better quality of life in patients with fluid in the belly due to liver scarring (cirrhosis), compared with current standard of care.
The liver can be damaged by excessive alcohol and viral infections. If liver damage continues this scarring leads to permanent damage. It causes a painful buildup of fluid in the abdomen (ascites). Drugs can treat this, but may stop working, leading to untreatable ascites. A liver transplant is then the best option. However, many do not receive a transplant due to concerns about their alcohol use or lack of donors. Life expectancy is on average six months and palliative care is needed.
Current palliative care for untreatable ascites involves coming into hospital for 1-2 days, putting a thin tube into the abdomen for a few hours and draining the fluid. This reduces pain from ascites. However, as the ascites builds up quickly, hospital visits are needed every 10-14 days.
For people with untreatable ascites due to cancer, palliative care involves placing another tube, an LTAD, into their abdomen. This tube is fitted in hospital but stays in place for months. Nurses/carers then drain smaller amounts of fluid regularly in the community. LTADs avoid frequent hospital visits and can improve quality of life. LTADs are not routinely offered to people with cirrhosis.
We conducted a feasibility study where half the participants received LTADs and half continued with standard hospital drainage. The study went well, with no major issues. We now need a larger study to understand the risks/benefits of palliative LTADs in people with cirrhosis. In this larger study we will measure quality of life for both the participants and their carers. The study has been designed with help of the patients/caregivers who are part of the research team.REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0164
Date of REC Opinion
8 Jul 2022
REC opinion
Further Information Favourable Opinion