一项前瞻性多中心试验，评估使用超声造影对肝脏局灶性病变进行特征性描述的新方法。

Prospective multicenter trial evaluating a novel method of characterizing focal liver lesions using contrast-enhanced sonography.

作者信息

Leen Edward, Ceccotti Piercarlo, Kalogeropoulou Christina, Angerson Wilson J, Moug Susan J, Horgan Paul G

机构信息

Department of Radiology, Glasgow Royal Infirmary, Alexandra Parade, Glasgow, Scotland G31 2ER.

出版信息

AJR Am J Roentgenol. 2006 Jun;186(6):1551-9. doi: 10.2214/AJR.05.0138.

DOI:10.2214/AJR.05.0138

PMID:16714643

Abstract

OBJECTIVE

The purpose of this study was to assess the clinical value and potential impact of SonoVue-enhanced sonography in the characterization of focal liver lesions.

SUBJECTS AND METHODS

This study included 127 patients with 82 malignant and 52 benign lesions in the liver. Contrast-enhanced sonography was performed using nonlinear imaging modes at low mechanical index (0.1-0.3) to enable real-time visualization of arterial, portal, and late-phase enhancement. Digital recordings of unenhanced sonography and contrast-enhanced sonography were reviewed by on-site investigators and two off-site blinded interpreters. The final diagnosis was based on consensus interpreting of all examinations by another two expert observers with access to CT, MRI, and histologic data; the diagnostic accuracy of contrast-enhanced sonography in identifying the lesion as benign, malignant, or indeterminate and as actual tumor type was compared with baseline sonography.

RESULTS

For on-site investigators, contrast-enhanced sonography reduced the number of indeterminate diagnoses by 67% and improved the sensitivity and specificity to 90.2% and 80.8%, respectively (p < 0.001). For off-site interpreters, contrast-enhanced sonography reduced the number of indeterminate diagnoses by 51-56% (p < 0.001); significantly improved sensitivity and specificity to 90.8-95.4% and 83.7-89.8%, respectively (p < 0.001); eliminated observers' variability (kappa coefficient: 0.66-0.77); and showed no significant difference in all comparisons in the analysis of lesions measuring less than 1.5 cm, 1.5-2.5 cm, and all sizes combined. Contrast-enhanced sonography did not rely on availability of clinical history to enable the diagnoses, and it reduced the need for further imaging investigations 23.7% to 90.4%.

CONCLUSION

Contrast-enhanced sonography improves the characterization of focal liver lesions and may limit the need for further investigations.

摘要

目的

本研究旨在评估超声造影增强超声在肝脏局灶性病变特征描述中的临床价值及潜在影响。

对象与方法

本研究纳入了127例肝脏有82个恶性病变和52个良性病变的患者。采用低机械指数（0.1 - 0.3）的非线性成像模式进行超声造影，以实现动脉期、门脉期和延迟期增强的实时可视化。未增强超声和超声造影的数字记录由现场研究人员和两名远程盲法解读人员进行审查。最终诊断基于另外两名可获取CT、MRI和组织学数据的专家观察者对所有检查结果的一致解读；将超声造影在鉴别病变为良性、恶性或不确定以及实际肿瘤类型方面的诊断准确性与基线超声进行比较。

结果

对于现场研究人员，超声造影使不确定诊断数量减少了67%，敏感性和特异性分别提高到90.2%和80.8%（p < 0.001）。对于远程解读人员，超声造影使不确定诊断数量减少了51 - 56%（p < 0.001）；敏感性和特异性显著提高，分别达到90.8 - 95.4%和83.7 - 89.8%（p < 0.001）；消除了观察者间的变异性（kappa系数：0.66 - 0.77）；并且在分析小于1.5 cm、1.5 - 2.5 cm以及所有大小组合的病变时，所有比较中均未显示出显著差异。超声造影不依赖临床病史进行诊断，并且将进一步影像学检查的需求减少了23.7%至90.4%。