O10 ELUCIDATE trial: non-invasive tests to detect and direct cirrhosis management do not improve survival or the incidence of severe decompensation

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Introduction Cirrhosis is often diagnosed late, limiting opportunities for surveillance and treatment of portal hypertension (PHTN) or hepatocellular cancer (HCC). ELUCIDATE, a multicentre, two arm, parallel group randomised controlled trial investigated use of the Enhanced Liver Fibrosis (ELF) test to facilitate earlier detection of cirrhosis and treatment of PHTN or HCC, to improve survival compared to standard best care (SC) in people with chronic liver disease (CLD). Methods Thirty-seven UK centres screened 1,303 CLD patients. Those eligible (ELF>8.4) were randomised to ELF guided management (cirrhosis screening if ELF>9.5) (438), or SC (440). All participants were reviewed every 6 months for 30 months with investigations for PHTN and HCC started if cirrhosis was suspected, and complications treated according to best practice. Long-term follow-up (LFU) was performed at 10 years by interrogating routine national data sources. Time from randomisation to first severe complication of cirrhosis (FSCC) due to PHTN, HCC or liver death is reported; deaths from other causes were treated as competing events. The equality of cumulative incidence functions between trial arms was investigated with Gray’s test. Results FSCC was recorded for 122 patients (63% bacterial peritonitis), with 99 additional non-liver deaths. Median time from randomisation to FSCC was 5.1 years (IQR 1.8, 7.1) ELF v. 2.3 years (IQR 0.4, 2.9) SC, with no statistically significant difference between arms (HRadj = 0.91, 95% CI: 0.63, 1.30, p=0.60). After diagnosis of cirrhosis FSCC was recorded for 49/279 (17.6%) ELF arm and 9/18 (50%) SC patients. Baseline ELF test score predicted FSCC (HR = 1.32 [95% CI 1.2, 1.5] p< 0.001). There were 152 deaths from any cause (77 ELF, 75 SC). Median survival was 7.8 years (IQR 4.6, 9.8) with no statistically significant difference between arms (HRadj = 0.89, 95% CI: 0.64, 1.24, p=0.49). Death or incurable HCC was less frequently FSCC in the ELF arm (4/62 v 12/60); (HR = 0.28 [0.10, 0.74] p=0.017). Conclusions ELF facilitated early detection of cirrhosis and risk, creating opportunities for interventions. Compared to standard care, 30 months ELF-directed cirrhosis surveillance and management was not associated with reductions in mortality, or the incidence and timing of the first severe complication of cirrhosis, even though this was less likely death or incurable HCC. Any benefits associated with early diagnosis of cirrhosis are likely to be few and modest at the cost of more invasive testing.

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