Accuracy of Transient Elastography in Assessing Fibrosis at Diagnosis in Naïve Patients With Primary Biliary Cholangitis: A Dual Cut-Off Approach.
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Cristoferi Laura, Calvaruso Vincenza, Overi Diletta, Viganò Mauro, Rigamonti Cristina, Degasperi Elisabetta, Cardinale Vincenzo, Labanca Sara, Zucchini Nicola, Fichera Anna, Di Marco Vito, Leutner Monica, Venere Rosanna, Picciotto Antonino, Lucà Martina, Mulinacci Giacomo, Palermo Andrea, Gerussi Alessio, D'Amato Daphne, Elisabeth O'Donnell Sarah, Cerini Federica, De Benedittis Carla, Malinverno Federica, Ronca Vincenzo, Mancuso Clara, Cazzagon Nora, Ciaccio Antonio, Barisani Donatella, Marzioni Marco, Floreani Annarosa, Alvaro Domenico, Gaudio Eugenio, Invernizzi Pietro, Carpino Guido, Nardi Alessandra, Carbone Marco, Italian PBC Registry
Аннотация
APPROACH AND RESULTS: We collected data from 167 consecutive treatment-naïve PBC patients who underwent liver biopsy (LB) at diagnosis at six Italian centers. VCTE examinations were completed within 12 weeks of LB. Biopsies were scored by two blinded expert pathologists, according to the Ludwig system. Diagnostic accuracy was estimated using the area under the receiver operating characteristic curves (AUROCs) for AF (Ludwig stage ≥III). Effects of biochemical and clinical parameters on liver stiffness measurement (LSM) were appraised. The derivation cohort consisted of 126 patients with valid LSM and LB; VCTE identified patients with AF with an AUROC of 0.89. LSM cutoffs ≤6.5 and >11.0 kPa enabled to exclude and confirm, respectively, AF (negative predictive value [NPV] = 0.94; positive predictive value [PPV] = 0.89; error rate = 5.6%). These values were externally validated in an independent cohort of 91 PBC patients (NPV = 0.93; PPV = 0.89; error rate = 8.6%). Multivariable analysis found that the only parameter affecting LSM was fibrosis stage. No association was found with BMI and liver biochemistry.
CONCLUSIONS: In a multicenter study of treatment-naïve PBC patients, we identified two cutoffs (LSM ≤6.5 and >11.0 kPa) able to discriminate at diagnosis the absence or presence, respectively, of AF in PBC patients, with external validation. In patients with LSM between these two cutoffs, VCTE is not reliable and liver biopsy should be evaluated for accurate disease staging. BMI and liver biochemistry did not affect LSMs.