Macken, Lucia, Bremner, Stephen, Gage, Heather, Touray, Morro, Williams, Peter, Crook, David, Mason, Louise, Lambert, Debbie, Evans, Catherine J, Cooper, Max, Timeyin, Jean, Steer, Shani, Austin, Mark, Parnell, Nick, Thomson, Sam J, Sheridan, David, Wright, Mark, Isaacs, Peter, Hashim, Ahmed and Verma, Sumita (2020) Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis. Alimentary Pharmacology and Therapeutics, 52 (1). pp. 107-122. ISSN 0269-2813

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Abstract

Background
Palliative care remains suboptimal in end‐stage liver disease.

Aim
To inform a definitive study, we assessed palliative long‐term abdominal drains in end‐stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison.

Methods
A 12‐week feasibility nonblinded randomised controlled trial comparing large‐volume paracentesis vs long‐term abdominal drains in refractory ascites due to end‐stage liver disease with fortnightly home visits for clinical/questionnaire‐based assessments. Study success criteria were attrition not >50%, <10% long‐term abdominal drain removal due to complications, the long‐term abdominal drain group to spend <50% ascites‐related study time in hospital vs large‐volume paracentesis group and 80% questionnaire/interview uptake/completion.

Results
Of 59 eligible patients, 36 (61%) were randomised, 17 to long‐term abdominal drain and 19 to large‐volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long‐term abdominal drain group vs large‐volume paracentesis group) were 0 (0‐1) vs 4 (3‐7); week 12 serum albumin (g/L) and serum creatinine (μmol/L) were 29 (26.5‐32.5) vs 30 (25‐35) and 104.5 (81‐115.5) vs 127 (63‐158) respectively. Total attrition was 42% (long‐term abdominal drain group 47%, large‐volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites‐related costs and percentage study time in hospital were lower in the long‐term abdominal drain group, £329 (253‐580) vs £843 (603‐1060) and 0% (0‐0.74) vs 2.75% (2.35‐3.84) respectively. Self‐limiting cellulitis/leakage occurred in 41% (7/17) in the long‐term abdominal drain group vs 11% (2/19) in the large‐volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long‐term abdominal drains could transform the care pathway.

Conclusions
The REDUCe study demonstrates feasibility with preliminary evidence of long‐term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation.

Item Type:	Article
Keywords:	Liver cirrhosis, quality of life, economics, palliative care
Schools and Departments:	Brighton and Sussex Medical School > Brighton and Sussex Medical School Brighton and Sussex Medical School > Clinical and Experimental Medicine Brighton and Sussex Medical School > Primary Care and Public Health
Subjects:	R Medicine
Depositing User:	Sumita Verma
Date Deposited:	30 Apr 2020 09:35
Last Modified:	18 Jun 2020 15:30
URI:	http://sro.sussex.ac.uk/id/eprint/91097

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