J Gastrointestin Liver Dis, June 2017 Vol. 26 No 2: 139-143 1) Infectious Diseases Department, Fondazione IRCCS Policlinico S. Matteo, Medical School University of Pavia; 2) Clinical Epidemiology and Biometric Unit, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy Address for correspondence: Giovanna Ferraioli, MD Ultrasound Unit - Infectious Diseases Department, Fondazione IRCCS Policlinico S. Matteo, University of Pavia, Via Taramelli 5, Pavia 27100, Italy giovanna.ferraioli@unipv.it Received: 23.01.2017 Accepted: 20.03.2017 * Liver Fibrosis Study Group: Elisabetta Above, MD; Marco Annovazzi Lodi, MD; Giorgio Barbarini, MD; Rafaele Bruno, MD; Carolina Dellafore, MD; Marta Di Gregorio, MD; Roberto Gulminetti, MD; Paolo Lanzarini, MD; Serena Ludovisi, MD; Antonello Malftano, MD; Renato Maserati, MD; Giuseppe Michelone, MD; Mario Mondelli, MD; Stefano Novati, MD; Savino F.A. Patruno, MD; Gianluigi Poma, MD; Paolo Sacchi, MD; Domenico Zanaboni, MD Ruling-in and Ruling-out Signifcant Fibrosis and Cirrhosis in Patients with Chronic Hepatitis C Using a Shear Wave Measurement Method Giovanna Ferraioli 1 , Laura Maiocchi 1 , Rafaella Lissandrin 1 , Carmine Tinelli 2 , Annalisa De Silvestri 2 , and Carlo Filice 1 on behalf of the Liver Fibrosis Study Group* INTRODUCTION Liver fbrosis is the wound- healing response to chronic liver injury due to several etiological agents [1]. Fibrosis causes an increase of liver stifness that can be measured using non-invasive methods. Nowadays, with the availability of direct acting antiviral agents that are highly efective for the eradication of the hepatitis C virus (HCV), the histological staging of liver ORIGINAL PAPER ABSTRACT Aims: To prospectively assess the cutof values of a point shear wave measurement (SWM) method for ruling-in and ruling-out signifcant fbrosis and cirrhosis using transient elastography (TE) as the reference standard. Method: Consecutive patients with chronic hepatitis C were enrolled. Liver stifness was assessed with the SWM method implemented on the HI VISION Ascendus ultrasound system (Hitachi Ltd, Japan) and with the TE method of the FibroScan® device (Echosens, France). For staging signifcant fbrosis (F≥2) and cirrhosis (F=4) we used the TE cutofs of 7.0 and 12.0 kiloPascal (kPa), respectively. Te diagnostic performance of SWM was assessed by calculating the area under the receiver operating characteristic (AUROC) curve. Cutofs with specifcity or sensitivity > 90% were chosen to rule-in or rule-out F≥2 and F=4. Results: 445 individuals [235 males, 210 females; mean age, 61.1 (13.3) years] were studied: 190 (42.7%) individuals had F0-F1 fbrosis stage, 82 (18.4%) F2, 46 (10.3%) F3, and 127 (28.6%) F4 fbrosis stage. For ruling-in F≥2 the SWM cutof was 6.78 kPa [sensitivity, 76.9%(70.6-82.4); specifcity, 90.3% (85.0-94.3)] and for ruling-out it was 5.55 kPa [sensitivity, 90.6% (85.8-94.1); specifcity, 72.2% (64.9-78.6)]. For ruling-in F=4 the SWM cutof was 9.15 kPa [sensitivity, 83.3% (74.4-90.2); specifcity, 90.1% (86.0-93.2)] and for ruling-out it was 8.41 kPa [sensitivity, 90.6% (82.9-95.6); specifcity, 82.2% (77.3-86.4)]. AUROCs were 0.92 (0.89-0.94) for F≥2 and 0.94 (0.91-0.96) for F=4. Conclusions. In clinical practice, the use of a dual cutof of SWM may increase the confdence in staging liver fbrosis with a non-invasive shear wave elastography technique. Key words: transient elastography – shear wave elastography – liver cirrhosis – chronic hepatitis C – liver stifness. Abbreviations: ARFI: acoustic radiation force impulse; AUROC: area under the ROC curve; CCC: concordance correlation coefcient; IQR/M: interquartile range/median; LSM: liver stifness measurement; ROC: receiver operating characteristic; pSWE: point shear wave elastography; SWM: shear wave measurement; TE: transient elastography; US: ultrasound. Available from:http://www.jgld.ro/wp/archive/y2017/n2/a9/ DOI: http://dx.doi.org/10.15403/jgld.2014.1121.262.fer fbrosis is no longer crucial for starting the treatment of patients with chronic hepatitis C. In fact, non-invasive methods have been accepted also by clinical guidelines [2, 3]. Te guidelines of the European Association for the Study of the Liver (EASL), produced together with the Asociación Latinoamericana para el Estudio del Hígado (ALEH), have suggested that in patients with viral hepatitis there are two clinically relevant endpoints: the detection of significant fibrosis and the detection of cirrhosis [2]. Moreover, they have pointed out that in HCV- infected patients the detection of cirrhosis is important to guide treatment. Transient elastography (TE) was the frst available shear wave-based elastography method for the assessment of liver stifness and is now considered the reference standard [2]. Transient elastography requires a dedicated system. Over the