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J Am Coll Radiol. 2019 Dec;16(12):1656-1662. doi: 10.1016/j.jacr.2019.05.020. Epub 2019 Jun 4.

ACR Ultrasound Liver Reporting and Data System: Multicenter Assessment of Clinical Performance at One Year.

Author information

1
Department of Radiology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan. Electronic address: johnmilletmd@gmail.com.
2
Department of Radiology, Stanford University, Stanford, California.
3
Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, California.
4
Department of Radiology, Mayo Clinic, Phoenix, Arizona.
5
Department of Radiology, University of California, San Diego, San Diego, California.
6
Department of Radiology, Einstein Medical Center, Philadelphia, Pennsylvania.
7
Department of Radiology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan.

Abstract

PURPOSE:

The aim of this study was to evaluate the clinical performance of the ACR's Ultrasound Liver Reporting and Data System (US LI-RADS™) for detecting hepatocellular carcinoma (HCC) in patients at high risk for HCC.

METHODS:

In this retrospective, multicenter study, 2,050 patients at high risk for HCC (1,078 men and 972 women; mean age, 57.7 years) at five sites in the United States had undergone screening liver ultrasound from January 2017 to February 2018, and US LI-RADS observation categories and visualization scores were assigned on a clinical basis. Ultrasound reports and patient records were retrospectively reviewed and follow-up imaging studies and/or pathologic reports recorded. Descriptive statistics were generated, and multivariate logistic regression analysis was used to analyze the relationship of clinical and reader-based predictors of limited visualization. Diagnostic performance data were calculated in the subset of patients with confirmatory testing.

RESULTS:

The most common indications for HCC screening were cirrhosis (n = 1,054 [51.4%]), noncirrhotic hepatitis B virus infection (n = 555 [27.1%]), and noncirrhotic hepatitis C virus infection (n = 234 [11.4%]). US LI-RADS observation categories assigned were US-1 (negative) in 90.4% (n = 1,854), US-2 (subthreshold) in 4.6% (n = 95), and US-3 (positive) in 4.9% (n = 101). Visualization scores were A (no or minimal limitations) in 76.8% (n = 1,575), B (moderate limitations) in 18.9% (n = 388), and C (severe limitations) in 4.2% (n = 87). Confirmatory tests, including multiphase contrast-enhanced CT or MRI (n = 331) or histopathology (n = 18), were available for 349 patients (17.0%). The sensitivity of US LI-RADS in this subset of patients was 82.4%, specificity was 74.2%, positive predictive value was 35.3%, and negative predictive value was 96.1%.

CONCLUSIONS:

Approximately 90% of US LI-RADS screening examinations were negative, 5% subthreshold, and 5% positive. Visualization scores were diagnostically acceptable in the vast majority (>95%) of examinations. US LI-RADS emphasized sensitivity and negative predictive value, which are key characteristics of a screening test.

KEYWORDS:

LI-RADS; Ultrasound; hepatocellular carcinoma; screening; surveillance

PMID:
31173745
DOI:
10.1016/j.jacr.2019.05.020

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