Diagnosis of hepatic nodules 20 mm or smaller in cirrhosis: ... : Hepatology (original) (raw)

Hepatobiliary Malignancies

Diagnosis of hepatic nodules 20 mm or smaller in cirrhosis: Prospective validation of the noninvasive diagnostic criteria for hepatocellular carcinoma

Forner, Alejandro1; Vilana, Ramón2; Ayuso, Carmen2; Bianchi, Lluís2; Solé, Manel3; Ayuso, Juan Ramón2; Boix, Loreto1; Sala, Margarita1; Varela, María1; Llovet, Josep M1,4; Brú, Concepció2; Bruix, Jordi1*

1 BCLC group, Liver Unit, IDIBAPS, CIBERehd, Hospital Clinic, University of Barcelona, Spain

2 Radiology Unit, IDIBAPS, CIBERehd, Hospital Clinic, University of Barcelona, Spain

3 Pathology Department, IDIBAPS, CIBERehd, Hospital Clinic, University of Barcelona, Spain

4 Mount Sinai Liver Cancer Program, Division of Liver Disease, Department of Medicine, Mount Sinai School of Medicine, New York, NY

*Address reprint requests to: BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIPAPS, CIBERehd, c/ Villarroel 170, Barcelona, 08036, Catalonia, Spain

Email:[email protected]

Received 15 May 2007; Accepted 6 August 2007

Published online in Wiley InterScience (www.interscience.wiley.com).

Grant sponsor: Instituto de Salud Carlos III; Grant Numbers: PI 05/150 PI 06/132; Grant sponsor: NIH-NIDDK; Grant Number: 1R01DK076986-0; Grant sponsor: Instituto de Salud Carlos III; Grant Number: PI 05/645; Grant sponsor: BBVA foundation; Grant sponsor: Fundación Científica de la Asociación Española de Ayuda contra el Cáncer, Spain.

Potential conflict of interest: Nothing to report.

Josep M. Llovet is Professor of Research at Institut Català de Recerca Avancada (ICREA, IDIBAPS, Hospital Clinic).

fax: (34) 93-227-57-92

Abstract

This study prospectively evaluates the accuracy of contrast-enhanced ultrasound (CEUS) and dynamic magnetic resonance imaging (MRI) for the diagnosis of nodules 20 mm or smaller detected during ultrasound (US) surveillance. We included 89 patients with cirrhosis [median age, 65 years; male 53, hepatitis C virus 68, Child-Pugh A 80] without prior hepatocellular carcinoma (HCC) in whom US detected a small solitary nodule (mean diameter, 14 mm). Hepatic MRI, CEUS, and fine-needle biopsy (gold standard) (FNB) were performed at baseline. Non-HCC cases were followed (median 23 months) by CEUS/3 months and MRI/6 months. FNB was repeated up to 3 times and on detection of change in aspect/size. Intense arterial contrast uptake followed by washout in the delayed/venous phase was registered as conclusive for HCC. Final diagnoses were: HCC (n = 60), cholangiocarcinoma (n = 1), and benign lesions (regenerative/dysplastic nodule, hemangioma, focal nodular hyperplasia) (n = 28). Sex, cirrhosis cause, liver function, and alpha-fetoprotein (AFP) levels were similar between HCC and non-HCC groups. HCC patients were older and their nodules significantly larger ( P < 0.0001). First biopsy was positive in 42 of 60 HCC patients. Sensitivity, specificity, and positive and negative predictive values of conclusive profile were 61.7%, 96.6%, 97.4%, and 54.9%, for MRI, 51.7%, 93.1%, 93.9%, and 50.9%, for CEUS. Values for coincidental conclusive findings in both techniques were 33.3%, 100%, 100%, and 42%. Thus, diagnosis of HCC 20 mm or smaller can be established without a positive biopsy if both CEUS and MRI are conclusive. However, sensitivity of these noninvasive criteria is 33% and, as occurs with biopsy, absence of a conclusive pattern does not rule out malignancy. These results validate the American Association for the Study of Liver Disease (AASLD) guidelines. (Hepatology 2007.)

Abbreviations: AASLD, American Association for the Study of Liver Diseases; AFP, alpha-fetoprotein; CEUS, contrast- enhanced ultrasound; FNB, fine-needle biopsy; FPR, false-positive rate; HCC, hepatocellular carcinoma; MRI, magnetic resonance imaging; US, ultrasound; VIBE, Volumetric Interpolated Breath-hold Examination.