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

TY - JOUR

T1 - Randomised clinical trial

T2 - palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis

AU - Macken, Lucia

AU - Bremner, Stephen

AU - Gage, Heather

AU - Touray, Morro

AU - Williams, Peter

AU - Crook, David

AU - Mason, Louise

AU - Lambert, Debbie

AU - Evans, Catherine J

AU - Cooper, Max

AU - Timeyin, Jean

AU - Steer, Shani

AU - Austin, Mark

AU - Parnell, Nick

AU - Thomson, Sam J

AU - Sheridan, David

AU - Wright, Mark

AU - Isaacs, Peter

AU - Hashim, Ahmed

AU - Verma, Sumita

N1 - © 2020 John Wiley & Sons Ltd.

PY - 2020/7/1

Y1 - 2020/7/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85085696091&partnerID=8YFLogxK

U2 - 10.1111/apt.15802

DO - 10.1111/apt.15802

M3 - Article

C2 - 32478917

SN - 0269-2813

VL - 52

SP - 107

EP - 122

JO - Alimentary Pharmacology & Therapeutics

JF - Alimentary Pharmacology & Therapeutics

IS - 1

ER -