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Cited by 69Liver Diseases and ImmunityLiver Disease Diagnosis and TreatmentPediatric Hepatobiliary Diseases and Treatments

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 +29 more·2021·Hepatology
DOI 10.1002/hep.31810PMC PMC8518641
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Abstract

Background and Aims: Liver fibrosis holds a relevant prognostic meaning in primary biliary cholangitis (PBC). Noninvasive fibrosis evaluation using vibration‐controlled transient elastography (VCTE) is routinely performed. However, there is limited evidence on its accuracy at diagnosis in PBC. We aimed to estimate the diagnostic accuracy of VCTE in assessing advanced fibrosis (AF) at disease presentation in PBC. 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.

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  • LSM values were reported to identify the absence or presence of advanced liver fibrosis in treatment-naive patients.

    “In another study, LSM values were reported to identify the absence or presence of advanced liver fibrosis in treatment-naive patients.125”

    From Primary biliary cholangitis. (2024) · cites this paper as [125]

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Authors
Cristoferi, L., Calvaruso, V., Overi, D., Viganò, M., Rigamonti, C., Degasperi, E., Cardinale, V., Labanca, S., Zucchini, N., Fichera, A., Di Marco, V., Leutner, M., Venere, R., Picciotto, A., Lucà, M., Mulinacci, G., Palermo, A., Gerussi, A., D’Amato, D., Elisabeth O’Donnell, S., Cerini, F., De Benedittis, C., Malinverno, F., Ronca, V., Mancuso, C., Cazzagon, N., Ciaccio, A., Barisani, D., Marzioni, M., Floreani, A., Alvaro, D., Gaudio, E., Invernizzi, P., Carpino, G., Nardi, A., Carbone, M., & on the behalf of the Italian PBC Registry
Affiliations
  • Azienda Ospedaliera San Gerardo (IT)
  • University of Palermo (IT)
  • Sapienza University of Rome (IT)
  • University of Milan (IT)
  • Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT)
  • University of Genoa (IT)
  • Section of Gastroenterology and Hepatology, PROMISE,University of Palermo,Palermo,Italy
  • Azienda Ospedaliero Universitaria Maggiore della Carita (IT)
  • Division of Gastroenterology,Center for Autoimmune Liver Diseases,Department of Medicine and Surgery,University of Milano‐Bicocca,Monza,Italy
  • Department of Translational Medicine,Università degli Studi del Piemonte Orientale “A. Avogadro”,Novara,Italy
  • University of Padua (IT)
  • University of Milano-Bicocca (IT)
  • Marche Polytechnic University (IT)
  • Foro Italico University of Rome (IT)
  • University of Rome Tor Vergata (IT)
Corresponding author
Carbone, Marco
ORCID
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2021-05-28
Volume
74
Issue
3
Pages
1496-1508
ISSN
  • 0270-9139 (ISSN-L)
  • 1527-3350
DOI
10.1002/hep.31810
PMC
PMC8518641
OpenAlex
W3137152892
Cited by
69
References
9
Citations by year
2026: 15 · 2025: 13 · 2024: 13 · 2023: 12 · 2022: 14 · 2021: 2
FWCI
5.70
Type
journal article
Language
en
Open access
Licence
Locations
  • Hepatology (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
  • IRIS UniPA (University of Palermo) (submittedVersion, other-oa)
  • Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion, cc-by-nc)
  • BOA (University of Milano-Bicocca) (submittedVersion, cc-by-nc)
  • IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, cc-by-nc)
  • Università Politecnica delle Marche (Università Politecnica delle Marche) (submittedVersion)
  • Padua Research Archive (University of Padova) (submittedVersion, cc-by-nc)
Funders
  • Gilead Sciences
  • Ministero dell’Istruzione, dell’Università e della Ricerca
  • Università degli Studi di Roma Tor Vergata
  • American Medical Association Foundation
Topics
  • Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
  • Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
  • Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
Keywords
primary biliary cirrhosis, liver fibrosis, vibration-controlled transient elastography, liver stiffness measurement, advanced fibrosis, noninvasive fibrosis assessment, liver biopsy, diagnostic accuracy, treatment-naive patients, fibrosis staging
MeSH terms
Female, Humans, Liver Cirrhosis, Liver Cirrhosis, Biliary, Male, Middle Aged, ROC Curve, Sensitivity and Specificity, Area Under Curve, Elasticity Imaging Techniques

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