Enhanced liver fibrosis test predicts transplant‐free survival in primary sclerosing cholangitis, a multi‐centre study

Abstract

are among the inventors and patent holders for the ELF® Test. William Rosenberg receives consultancy fees from Siemens. Financial support:MV is funded by the Norwegian PSC Research Center. List of abbreviations:

Cholangiocarcinoma is associated with a raised enhanced liver fibrosis score independent of primary sclerosing cholangitis

“…Furthermore, we observed that PSC patients with CCA had significantly higher ELF scores than those affected by PSC alone . Both these findings have been subsequently validated in a large international multicentre study . It is unclear whether the association of elevated ELF test with CCA diagnosed in PSC patients is due to the advanced stage of background liver fibrosis or it is related to the biological features of CCA.…”

“…The ELF test is a commercially available, well‐validated test, which has demonstrated good diagnostic accuracy for the detection of moderate and severe fibrosis and proven good prognostic performance for predicting clinical outcomes in viral hepatitis, primary biliary cholangitis and nonalcoholic fatty liver disease/steatohepatitis . Recently, several reports have demonstrated the utility of ELF as a prognostic marker in PSC, showing that a higher ELF test is associated with reduced transplant‐free survival . Incidental findings of elevated ELF scores in patients with CCA amongst the PSC patients in these studies raised questions regarding the basis for this association, and in particular whether it was related to more advanced liver disease in PSC + CCA patients compared to patients with PSC alone or whether ELF score reflects some biological property of the tumours, thus introducing ELF test as a putative risk stratification tool in CCA surveillance.…”

“…[26][27][28] Recently, several reports have demonstrated the utility of ELF as a prognostic marker in PSC, showing that a higher ELF test is associated 07 (1.03-1.11 with reduced transplant-free survival. 13,14,29 Incidental findings of elevated ELF scores in patients with CCA amongst the PSC patients in these studies raised questions regarding the basis for this association, and in particular whether it was related to more advanced liver disease in PSC + CCA patients compared to patients with PSC alone or whether ELF score reflects some biological property of the tumours, thus introducing ELF test as a putative risk stratification tool in CCA surveillance. The ELF score is based on an algorithm combining three circulating markers of hepatic matrix metabolism, reflecting the amount of fibrotic tissue in the liver.…”

“…13 Both these findings have been subsequently validated in a large international multicentre study. 14 It is unclear whether the association of elevated ELF test with CCA diagnosed in PSC patients is due to the advanced stage of background liver fibrosis or it is related to the biological features of CCA. Indeed, CCA is characterised by an abundant desmoplastic reaction independent of surrounding tissue fibrosis that may affect the results of the ELF test.…”

Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis

“…The ELF test distinguished between mild and severe disease defined by clinical outcome (transplantation or death) with an area under the curve (AUC) of 0.81 (95% CI, 0.73‐0.87) and optimal cutoff of 10.6 (sensitivity, 70.2%; specificity, 79.1%). A validation study in external cohorts from seven countries confirmed the previous data . As with other serum biomarkers, ELF can be elevated secondary to acute inflammation or obstruction, and these need to be accounted for assessing responses.…”