Summary
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.
Trial registration: ISRCTN30697116, date assigned: 07/10/2015.
Background & Aims
The incidence and mortality from end‐stage liver disease is increasing, with a minority eligible for liver transplantation. Ascites is the commonest complication of end‐stage liver disease and large volume paracentesis (LVP) the accepted management strategy where refractory to medical treatment. In malignant ascites, permanent indwelling peritoneal catheters (PIPC) are an established palliative intervention. The aims are to describe available data using permanent indwelling peritoneal catheters in refractory ascites due to end‐stage liver disease.
Methods
Using systematic review methodology, databases were searched (MEDLINE, EMBASE, CINAHL [The Cumulative Index to Nursing and Allied Health Literature], Google Scholar and Cochrane Database of Systematic Reviews from inception‐March 2018), for studies combining ascites and palliative care. Inclusion and exclusion criteria were applied to results.
Results
Following initial and updated searches, 225 studies were identified for full text review, 18 were eligible for final analysis. The studies displayed heterogeneity in design, reported on different indwelling catheters and were overall of low quality. Only one pilot randomised controlled trial was identified, of PIPC versus LVP, recruiting one patient into each arm. Technical insertion success was 100%, with low rates of non‐infectious complications (<12%), none life threatening. Rates of bacterial peritonitis were not unacceptably high (12.7%), considering this was an end‐stage liver disease population and only a minority utilising long‐term prophylactic antibiotics. Only one study attempted quality‐of‐life assessments; none addressed potential health economic benefits.
Conclusions
Despite lack of well‐designed studies, preliminary data suggests low significant complication rates; however safety and efficacy of permanent indwelling peritoneal catheters in end‐stage liver disease remains to be confirmed. Further prospective randomised controlled trials are warranted, potentially translating permanent indwelling peritoneal catheters into improved palliative care in end‐stage liver disease.
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