Palliative Long-term Abdominal Drains Versus Repeated Drainage in Untreatable Ascites Due to Advanced Cirrhosis: A Randomised Controlled Trial (REDUCe 2 Study)
Recipient organisationUniversity Hospitals Sussex NHS Foundation TrustSource-published name: University Hospitals Sussex NHS Foundation Trust
Funding£1.9M
PeriodMay 2022 — Jan 2027
In plain English
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Every three months, 310 patients with end-stage liver disease will be randomly assigned to receive either a permanent abdominal drain they can use at home or repeated hospital visits for fluid removal. The trial compares whether long-term abdominal drains (LTADs) improve quality of life over standard large-volume paracentesis (LVP) for people with untreatable fluid buildup, or ascites, caused by advanced cirrhosis. This matters because refractory ascites typically leaves patients with only six months of transplant-free survival, requiring frequent hospital stays for drainage. LTADs allow community nurses to drain fluid at home two to three times weekly, while LVP patients attend hospital every 10–14 days for larger-volume drainage. The current standard of care is burdensome and poorly suited to end-of-life care. If LTADs prove superior, the NHS could shift from hospital-based to home-based drainage for this group, reducing hospital admissions and improving quality of life in the final months. The trial also includes a cost-effectiveness analysis and qualitative interviews with 30 patients, 20 caregivers, and 20 healthcare professionals to understand real-world barriers and benefits. With 90% power to detect an 8-point difference in quality-of-life scores, the results could directly change clinical guidelines for an underserved patient population.
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RESEARCH QUESTION: Do palliative long-term abdominal drains (LTADs) result in better health related quality of life (HRQoL) in patients with refractory ascites due to end-stage liver disease (ESLD) compared with standard of care (large volume paracentesis, LVP)? BACKGROUND: Refractory ascites confers a median transplant-free survival of six mths and needs repeated hospitalisation for drainage (LVP). LTADs allow home drainage but are not routinely used in ESLD. Our REDUCe study (LVP vs. LTADs in ESLD) demonstrated feasibility to proceed with a definitive trial. AIM: To assess whether LTADs result in better HRQoL vs. LVP in patients with refractory ascites due to ESLD. METHODS: We will recruit patients with ESLD and refractory ascites, randomised 1:1 to either LTADs or LVP. Community nurses will visit LTAD patients at home, 2-3 times a week to perform drainage (1-2 L per visit). LVP patients will attend hospital every 10-14 days with 5-15 L of ascites drainage. Research staff will visit ALL participants at home fortnightly for 3-mths for safety monitoring and questionnaire-based assessments (Ascites Q, SFLDQoL, EQ-5D-5L, CRRS). The primary outcome will be HRQoL assessed by the SFLDQoL questionnaire. An embedded qualitative study will explore perspectives on LTADs and LVP by patients (n=30), caregivers (n=20) and health care professionals (n=20). The minimal clinically important difference (MCID) is the mean change in HRQoL score for patients reporting a minimal yet perceptible change in HRQoL between baseline and follow-up assessments. We have selected an MCID of 8 points. REDUCe study data showed the pooled baseline mean across SFLDQoL domains (excluding sexual function) was 56.4 (SD=26.1). With 93 participants in each group, we will have 90% power for 5% significance to detect a difference in adjusted mean SFLDQoL scores of 8 points between the LTAD and LVP groups at the end of 3-mths (effect size 0.31). We will assume a correlation between baseline and follow-up measurements of 0.48 (lower bound of 95% CI, REDUCe study data). With an expected 40% attrition, we will recruit 310 patients in total for the trial. Statistical analysis will follow intention-to-treat principles, performing for the primary outcome, a longitudinal analysis of covariance by fitting a mixed effects linear regression model. Qualitative data will be analysed using thematic analysis and triangulation. A probabilistic cost effectiveness analysis will be conducted, service use being assessed by the AHCR and an in house designed hospital use questionnaire. DELIVERY TIMELINES: Study duration 57-mths: 6-mths set up; 18-mths internal pilot with STOP/GO criteria; 29-mths main trial and 4-mths data analysis/dissemination. The pilot will recruit 84 patients from 24 sites. Assuming a successful pilot, 11 more sites will be opened over 5-mths, recruiting the remaining 226 patients from 35 sites. IMPACT: This large UK trial will improve end of life care for an underserved group.
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