RESUMEN
Background: The American College of Radiology (ACR) developed the contrast-enhanced ultrasound (CEUS) Liver Imaging Reporting and Data System (LI-RADS) for pure blood contrast agents, but Sonazoid was not included. Modifications to LI-RADS have been proposed for Sonazoid. The purpose of this meta-analysis was to identify and compare the diagnostic efficacy of the two LI-RADS algorithms of Sonazoid. Methods: We searched the PubMed, MEDLINE, Web of Science, Embase, and Cochrane Library databases from databases inception to August 31, 2023, to find original studies on the ACR LI-RADS and/or modified LI-RADS algorithm with Sonazoid used as the contrast agent in patients with high-risk hepatocellular carcinoma (HCC). A bivariate random-effects model was used. Data pooling, meta-regression, and sensitivity analysis were performed for meta-analysis. The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used to assess the methodological quality, and the Deeks funnel plot asymmetry test was used to evaluate the publication bias. Results: A meta-analysis of 10 studies with 1,611 observations was conducted. The pooled data for ACR LI-RADS category 5 (LR-5) and modified LR-5 were respectively as follows: pooled sensitivity, 0.70 [95% confidence interval (CI): 0.64-0.75] and 0.81 (95% CI: 0.76-0.86) (P<0.05); pooled specificity, 0.90 (95% CI: 0.82-0.94) and 0.87 (95% CI: 0.81-0.91) (P>0.05); and pooled area under the summary receiver operating characteristic curve, 0.84 and 0.91. The diagnostic performance of LI-RADS category M (LR-M) of the two algorithms was comparable. Study heterogeneity was observed. Conclusions: The results indicated that modified LR-5 algorithm demonstrated improved diagnostic sensitivity compared with the ACR LR-5 algorithm of Sonazoid, with differences observed between the different versions. Further research is needed to validate and explore the optimal diagnostic criteria for HCC using Sonazoid. Before the database search was conducted, this study was registered on PROSPERO (International Prospective Register of Systematic Reviews; CRD42023455220).
RESUMEN
Background: The contrast-enhanced ultrasound (CEUS) liver imaging reporting and data system (LI-RADS) is a standardized system for reporting liver nodules in patients at risk of developing hepatocellular carcinoma (HCC) and is only recommended for pure blood pool agents such as SonoVue®. A modified LI-RADS was proposed for Sonazoid®, a Kupffer cell-specific contrast agent. This meta-analysis was conducted to compare the diagnostic efficiency of the CEUS LI-RADS for SonoVue® and the modified LI-RADS for Sonazoid®. Methods: The PubMed, Medline, Web of Science, Embase, and Cochrane Library databases were systematically searched to retrieve studies on the diagnostic efficiency of the CEUS LI-RADS algorithms in diagnosing HCC using SonoVue® and/or Sonazoid® from January 2016 to June 2023. Histopathology or imaging follow-up served as the reference standards. Only articles published in English on retrospective or prospective studies with full reports were included in the meta-analysis. A bivariate random-effects model was used. Data pooling, meta-regression, and sensitivity analysis were performed for the meta-analysis. Deeks' funnel plot asymmetry test was used to evaluate publication bias, and the QUADAS-2 tool was used to assess the methodological quality of eligible studies. Results: In total, 26 studies comprising 8,495 patients with 9,244 lesions were included in the meta-analysis. The pooled data results for SonoVue® LI-RADS category 5 (LR-5) and Sonazoid® modified LR-5 were as follows: pooled sensitivity: 0.68 [95% confidence interval (CI): 0.64-0.73, I2=89.20%; P<0.01] and 0.82 (95% CI: 0.74-0.87, I2=85.39%; P<0.01) (P<0.05); pooled specificity: 0.93 (95% CI: 0.90-0.96, I2=86.52%; P<0.01) and 0.86 (95% CI: 0.79-0.91, I2=59.91%; P=0.01) (P<0.05); pooled area under the curve (AUC): 0.86 (95% CI: 0.82-0.89) and 0.91 (95% CI: 0.88-0.93) (P<0.05), respectively. The meta-regression analysis revealed that the study design, subject enrollment method, and reference standard contributed to the heterogeneity of SonoVue® LR-5, and the number of lesions was a source of heterogeneity for Sonazoid® modified LR-5. The diagnostic performance of the LI-RADS category M (LR-M) algorithms of SonoVue® and Sonazoid® was comparable. Conclusions: The Sonazoid® modified LR-5 algorithm had a higher diagnostic sensitivity, lower specificity, and higher AUC than SonoVue® LR-5.
RESUMEN
Background: Until now, there has been no systematic review or meta-analysis of direct head-to-head studies that compare two liver imaging reporting and data system (LI-RADS) algorithms, contrast-enhanced ultrasound (CEUS) LI-RADS and contrast-enhanced computed tomography/magnetic resonance imaging (CT/MRI) LI-RADS, for the diagnostic efficacy of hepatocellular carcinoma. The purpose of this study was to identify and head-to-head compare the diagnostic performance of both LI-RADS algorithms for hepatocellular carcinoma. Methods: We searched the PubMed, EMBASE, Web of Science, and Cochrane Library databases from the inception of each database to April 26, 2022, to find the comparative study of both LI-RADS algorithms for hepatocellular carcinoma at risk of patients who underwent both LI-RADS algorithms. Eligibility criteria included only studies published in English, full reports published, both retrospective and prospective studies. Liver histology or imaging follow-up results served as the reference standard. We analyzed the sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, and summary receiver operating characteristic curve to determine summary estimates. The Quality Assessment of Diagnostic Accuracy Studies was utilized to assess the methodological quality. Results: In 5 included studies (831 patients, 877 lesions), the pooled sensitivity and pooled specificity of CEUS LR-5 were 0.79, 0.81, and 0.78, 0.79 in CT/MRI LR-5, respectively. The pooled sensitivity and pooled specificity of CEUS LR-4/5 were 0.86, 0.70, and 0.93, 0.59 in CT/MRI LR-4/5, respectively. There was no obvious difference between the two LI-RADS algorithms for hepatocellular carcinoma, and there was no significant statistical difference between two LR-M algorithms for non-hepatocellular carcinoma malignancies. Conclusions: The results of our analysis demonstrated that CEUS LI-RADS has satisfactory diagnostic performance similar to that of CT/MRI LI-RADS, which provides a theoretical basis for the popularization of CEUS LI-RADS for diagnosing HCC. This work was supported by Sichuan Science and Technology Program (No. 2020YFS0211). We registered this study on the international prospective register of systematic reviews (PROSPERO, CRD42022328107) before the search step.