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

• DOI: 10.1111/apt.15802
• Publication Date: 2020-06-01T15:18:22Z
• Authors: Lucia Macken; Stephen Bremner; Heather Gage; Morro Touray; Peter Williams; David Crook; Louise Mason; Debbie Lambert; Catherine J. Evans; Max Cooper; Jean Timeyin; Shani Steer; Mark Austin; Nick Parnell; Sam J. Thomson; David Sheridan; Mark Wright; Peter Isaacs; Ahmed Hashim; Sumita Verma
• Keywords: Paracentesis

Summary Background Palliative care remains suboptimal in end‐stage liver disease. Aim To inform a definitive study, we assessed palliative long‐term abdominal drains disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make preliminary cost comparison. Methods A 12‐week feasibility nonblinded randomised controlled trial comparing large‐volume paracentesis vs refractory ascites due with fortnightly home visits for clinical/questionnaire‐based assessments. Study success criteria were attrition not >50%, <10% drain removal complications, the group spend <50% ascites‐related study time hospital 80% questionnaire/interview uptake/completion. Results Of 59 eligible patients, 36 (61%) randomised, 17 19 paracentesis. Following randomisation, median number (IQR) of ascitic (long‐term group) 0 (0‐1) 4 (3‐7); week 12 serum albumin (g/L) creatinine (μmol/L) 29 (26.5‐32.5) 30 (25‐35) 104.5 (81‐115.5) 127 (63‐158) respectively. Total was 42% 47%, 37%). Median community/hospital/social costs percentage lower group, £329 (253‐580) £843 (603‐1060) 0% (0‐0.74) 2.75% (2.35‐3.84) Self‐limiting cellulitis/leakage occurred 41% (7/17) 11% (2/19) group; peritonitis incidence 6% (1/17) Questionnaires/interview ≥80%; interviews indicated that could transform pathway. Conclusions The REDUCe demonstrates evidence acceptability/effectiveness/safety reduction health resource utilisation. Trial registration: ISRCTN30697116, date assigned: 07/10/2015.