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P66 Benefits of early cirrhosis detection may depend on effective linkage to cirrhosis management: exploratory analyses from the ELUCIDATE RCT

gutjnl · 2026-06-23 · canonical JSON source

20 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction The ELUCIDATE trial found no statistically significant reduction in mortality, incidence or timing of first severe cirrhosis complications (FSCC) with Enhanced Liver Fibrosis test (ELF) guided cirrhosis detection and management, compared to standard care (SC) despite EASL cirrhosis surveillance guidance highlighting that early treatment of varices and hepatocellular carcinoma (HCC) reduces morbidity and mortality. We hypothesised that the lack of improvement in clinical outcomes may be attributable to poor adherence to protocol-defined surveillance and interventions examining between-arm adherence and the association between baseline ELF score and clinical events.Methods Case report-form review determined adherence to protocol-defined care, by arm, over 30 months from randomization, including 6 monthly scheduled follow-up before and after diagnosis of cirrhosis; HCC surveillance (alpha-fetoprotein [AFP] testing and imaging) and interventions; endoscopic screening for varices, and prophylaxis. Association between baseline ELF score and the primary endpoint of FSCC was assessed 10 years post randomisation using routine healthcare data. Exploratory analyses examined the prognostic performance of the protocol defined ELF threshold (9.5).Results Baseline ELF score was a strong independent predictor of FSCC (positive predictive value of ELF>9.5 for FSCC = 26%). Each unit increase in ELF (centred at 9.5) was associated with a greater risk of FSCC (HR = 1.32, [95% CI 1.16–1.50]; p<0.001). Adherence to protocol-defined surveillance was poor in both arms. Pre-cirrhotic and post-cirrhotic visit compliance was low but higher in the ELF arm than SC (29.8% vs 19.7% and16.2% vs 21.1% respectively). After cirrhosis detection, compliance with timing of AFP and imaging for ELF and SC arms were 12.6% vs 11.8% and 29.5% vs 14.3% respectively. Endoscopic surveillance adherence was suboptimal with only 54.4% of ELF arm cirrhotic patients having at least one OGD compared to 60% in the SC arm. Only 56% of ELF and 43% of SC patients with varices received treatment.Conclusions While ELF effectively predicted risk of FSCC, poor adherence to cirrhosis surveillance and management protocols may have prevented early detection of cirrhosis translating into clinical benefit. If confirmed in the final analysis of ELUCIDATE this highlights the need to link the implementation of effective care pathways to strategies designed to improve early detection of cirrhosis.Conflict of interest: Sudeep Tanwar: None declared, Myka Ransom: None declared, Annah Muli: None declared, Deborah Stocken: None declared, Paul Richardson: None declared, Sulleman Moreea: None declared, Rebecca Jones: None declared, Chin Lye Ch’ng: None declared, James Neuberger: None declared, Peter Selby: None declared, William Rosenberg I have received grant support from Siemens Healthineers, I have provided national lectures for Siemens Healthineers, My institutions has received royalty payments in respect of ELF from Siemens from which I have benefitted.Applied for bursary: No.