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

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).

Is tumor biopsy necessary?

“…Therefore, this is only a level 4 study. Forner et al 56 also validated the old AASLD guidelines in their study. According to these guidelines, 2 concordant imaging methods are required for the diagnosis of HCC.…”

“…In the more recent literature, 2 additional level 1b studies could be identified 56,57 (Tables 6 and 7). In the study by Forner et al, 56 only patients with newly detected lesions between 5 and 20 mm in size were included, and CEUS and MRI were used as imaging modalities.…”

“…In the study by Forner et al, 56 only patients with newly detected lesions between 5 and 20 mm in size were included, and CEUS and MRI were used as imaging modalities. Conclusive lesions were defined as lesions with arterial hypervascularization and venous washout, and suspicious lesions were defined as lesions with arterial hypervascularization regardless of washout.…”

“…57 With respect to the current EASL and AASLD guidelines, it is obviously important to know the diagnostic accuracy of noninvasive criteria for small nodules. [1][2][3] Analyzing the 4 level 1b studies, we were able to extract data about the diagnostic accuracy with respect to the size from 2 studies 32,57 ; the study by Forner et al 56 was specifically designed to address this question (Table 8). Lesions 10 mm were rather infrequently HCC (14.6%), and the diagnostic sensitivity decreased with the size from 100% (for CT and MRI) for lesions > 20 mm to 10% to 50% (for CT) or 34% to 70% (for MRI) for lesions < 10 mm 32 or 10 mm.…”

“…These guidelines have been validated in 3 studies 56,58,59 (Tables 9 and 10). The prospective study by Leoni et al 58 used the EASL guidelines 3 to establish the diagnosis of HCC for 75 consecutive small lesions (10-30 mm) detected by ultrasonography.…”