Non-invasive assessment of liver fibrosis and portal hypertension in primary sclerosing cholangitis and primary biliary cholangitis: transient elastography, point share wave elastography and biomarkers

Background and Aims: There is an ongoing effort to identify non-invasive surrogates for staging liver disease and detecting clinically significant portal hypertension (CSPH), defined as the presence of gastro-oesophageal varices on endoscopy. Transient elastography performed by Fibroscan (F-TE) has a well-established role in the non-invasive assessment of liver fibrosis and is widely used in clinical practice. Point Share Wave Elastography (pSWE) is a new software-based technique that measures liver stiffness during B-mode ultrasonography. Data about its performance in primary cholestatic liver disease are limited. Aim of this study was to evaluate the performance of pSWE in primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) and its correlations with F-TE and the current scores of liver fibrosis and disease severity. The ability of liver stiffness measurement (LSM) and spleen stiffness measurement (SSM) performed by pSWE to detect CSPH in PSC and PBC was also assessed. Methods: Demographics, biochemistry, clinical and ultrasonographic data were prospectively collected from 152 PSC and 154 PBC patients. F-TE (Fibroscan®, Echosens, median kPa, IQR ＜30, SR ＞60%), pSWE (ElastoPQ, Philips Affiniti70G) and the most common clinical scores of fibrosis were obtained on the visit date. Correlations of TE and pSWE with scores and clinical variables were investigated. Since a recent liver biopsy was not available for most patients, F-TE was used as surrogate of histological fibrosis, adopting the fibrosis stage cut-offs validated in PSC and PBC. ROC curves were obtained in order to define optimal cut-offs for pSWE. Predictors of CSPH were evaluated in patients who had an upper-GI endoscopy within 12 months of the elastographic assessment. ROC curves were constructed to establish the performance of elastographic techniques and fibrosis scores in predicting CSPH. Results: pSWE LSM correlated significantly with F-TE, all clinical scores of fibrosis and the currently validated prognostic scores in PSC and PBC (P＞0.001). AUROCs (95%CI) for LSM pSWE were ≥0.93 for all fibrosis stages, with optimal cut-offs for fibrosis stage ≥1, ≥2, ≥3, =4 of 7.4, 8.5, 10.5 and 12.1 kPa in PSC and 7.7, 8.9, 9.6 and 13.3 kPa in PBC, respectively. 46 PSC and 53 PBC patients had an upper-GI endoscopy within 12 months of the elastographic assessment. CSPH was detected in 18 and 12 cases, respectively. SSM showed the best performance in predicting CSPH, with best cut-off 40.2 kPa for PSC and 50.1 kPa for PBC. In this cohort, the diagnostic performance of ElastPQ SSM in detecting CSPH was superior to the recently validated Baveno VI and Expanded Baveno VI criteria. Conclusions: This study provides evidence of the suitability of liver and spleen ElastPQ pSWE as valuable diagnostic and prognostic markers in PSC and PBC. In particular, ElastPQ SSM can be used as a reliable tool for the detection of CSPH in primary cholestatic liver disease.