REDUCe main manuscript draft 8 APT. R2. 25.04.2020.pdf (812.7 kB)
Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis
journal contribution
posted on 2023-06-07, 06:54 authored by Lucia MackenLucia Macken, Stephen BremnerStephen Bremner, Heather Gage, Morro Touray, Peter Williams, David Crook, Louise Mason, Debbie LambertDebbie Lambert, Catherine J Evans, Maxwell CooperMaxwell Cooper, Jean Timeyin, Shani Steer, Mark Austin, Nick Parnell, Sam J Thomson, David Sheridan, Mark Wright, Peter Isaacs, Ahmed Hashim, Sumita VermaSumita VermaBackground 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.
Funding
Pallative long-term tunnelled abdominal catheter verus large volume paracentesis in supporting individuals with refractory ascites due to end stage cirrhosis: a randomised controlled trial; G1835; NATIONAL INSTITUTE FOR HEALTH RESEARCH; PB-PG-0214-33068
History
Publication status
- Published
File Version
- Accepted version
Journal
Alimentary Pharmacology and TherapeuticsISSN
0269-2813Publisher
WileyExternal DOI
Issue
1Volume
52Page range
107-122Department affiliated with
- BSMS Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2020-04-30First Open Access (FOA) Date
2021-06-02First Compliant Deposit (FCD) Date
2020-04-29Usage metrics
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