Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis

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

[img] PDF - Accepted Version
Restricted to SRO admin only until 2 June 2021.

Download (832kB)

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

View download statistics for this item

📧 Request an update
Project NameSussex Project NumberFunderFunder Ref
Pallative long-term tunnelled abdominal catheter verus large volume paracentesis in supporting individuals with refractory ascites due to end stage cirrhosis: a randomised controlled trialG1835NATIONAL INSTITUTE FOR HEALTH RESEARCHPB-PG-0214-33068