Palliative Long-term Abdominal Drains vs. Large Volume Paracentesis for refractory ascites secondary to cirrhosis: study protocol for a randomised controlled trial

Background Ascites remains the most common complication of cirrhosis and a frequent reason for hospitalisation in advanced chronic liver disease (ACLD). Ascites is associated with significant symptom burden, caregiver workload and poor health-related quality of life (HRQoL). Once refractory to treatment, median survival is poor. Many with refractory ascites (RA) will neither receive a transjugular intrahepatic portosystemic shunt (TIPS) nor a liver transplant. Palliative care remains underutilised and evidence-based interventions focused on improving HRQoL are clearly needed. The standard of care for RA is repeated hospital ascites drainage with large volume paracentesis (LVP). Our earlier feasibility randomised controlled trial (RCT) (REDUCe) showed acceptability of palliative tunnelled long-term abdominal drains (LTADs), as well as preliminary evidence of safety and efficacy. The current REDUCe2 trial is a definitive national study designed to assess the impact of palliative LTADs on HRQoL in patients with RA due to ACLD. Methods/Design The REDUCe2 study is a pragmatic, multicentre, open-label, mixed-methods RCT being conducted in England, Scotland and Wales. Patients with RA secondary to ACLD who are ineligible for a liver transplant or TIPS will be randomised 1:1 to receive a LTAD or continue the current standard of care (LVP). Fortnightly home research visits will be conducted for 12 weeks in both arms. The primary outcome will be liver specific HRQoL assessed at 12 weeks using the Short Form Liver Disease Quality of Life questionnaire (SFLDQoL). Secondary outcomes include assessment of symptom burden (Ascites Questionnaire), health utilities (EQ-5D-5L tool), caregiver workload (Caregiver Roles and Responsibilities Scale - CRRS questionnaire), safety (including infection, acute kidney injury and other clinical outcomes), health resource utilisation and acceptability of the intervention by patients, caregivers and healthcare professionals. We aim to recruit a total of 310 patients (155 in each arm). Discussion Effective palliative care provision remains an unmet need in ACLD. The REDUCe2 study, the largest palliative interventional trial in the UK, aims to address this inequity for this vulnerable and underserved cohort. It has the potential to generate high quality evidence to optimise and enhance palliative care in RA. Trial registration: ISRCTN26993825, date registered: 15/08/2022