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超声内镜弹性成像有区别性地诊断胰腺肿块的准确度:多中心研究

发布日期:2014-1-29 12:40:11 文章来源:Endoscopy 作者次数:1348
    超声内镜弹性成像有区别性地诊断胰腺肿块的准确度:多中心研究
     
    A.  Săftoiu1,2, P.  Vilmann2, F.  Gorunescu3, J.  Janssen4, M.  Hocke5, M.  Larsen6, J.  Iglesias-Garcia7, P.  Arcidiacono8, U.  Will9, M.  Giovannini10, C.  Dietrich11, R.  Havre12, C.  Gheorghe13, C.  McKay14, D.  I.  Gheonea1, T.  Ciurea1 , on behalf of the European EUS Elastography Multicentric Study Group
    2丹麦哥本哈根大学Gentofte和Herlev医院外科肠胃病学
    3罗马尼亚克拉约瓦医学与制药大学生物统计与计算机学科
    4德国伍珀塔尔维滕/黑尔德克大学Helios Klinikum
    5德国迈宁根医院内科II部
    6丹麦欧登塞欧登塞大学医院外科部手术超声中心
    7西班牙圣地亚哥德孔波斯特拉医科大学肠胃病学科
    8意大利米兰圣拉斐尔生命健康大学胃肠病学和消化内镜组
    9德国格拉SRH Wald-Klinikum肠胃病科
    10法国马赛Paoli-Calmettes研究所内镜组
    11德国博爱医院根特海姆内科2部
    12挪威卑尔根海于克兰大学医院卑尔根大学与国立超声中心医药研究所,
    13罗马尼亚布加勒斯特Fundeni临床研究所胃肠病和肝病中心
    14英国格拉斯哥皇家医院肝胆外科
     
    背景与研究目的:
    超声内镜弹性成像技术代表了一项新的成像程序,它可以表征出病变组织与正常组织之间硬度和弹性的不同之处。这个研究的目的是为了评估超声内镜弹性成像技术在区别性诊断慢性胰腺炎肿块和胰腺癌肿块的有效性。
    患者与方法:
    这个研究组有患有胰腺肿块疾病的258例患者,包括前瞻性研究中的13所中心的患者。两位专家级医生使用所有记录下的视频片段作出诊断结论,然后通过定性分析测试读片者的变化性。通过计算个体弹性成像图的平均色彩直方图,运用后处理软件检测超声内镜弹性成像视频。然后根据定量信息计算内部读片者的差异性和方法的准确性。
    结果:
    定性分析所记录视频,结果显示Kappa系数值为0.72。分析内部读片者差异性,结果是单一测量组内相关系数变化幅度范围为0.86-0.94。分析数据平均色彩直方图,以175为基本界值,得出灵敏度93.4%,专属性66%,阳性预测值92.5%,阴性预测值68.9%,总体准确度85.4%。受试者操作特征曲线下面积(AUROC)为0.854(P < 0.0001 ),置信区间范围为0.804-0.894。
    结论: 
     

    良好的视频重现性和可靠地受试者操作特征曲线下面积分析参数验证了定量分析超声内镜弹性成像记录的价值。(Clinical Trials.gov标志:CT00909103)

     

    Original article
    Endoscopy 2011; 43(7): 596-603
    DOI: 10.1055/s-0030-1256314

    © Georg Thieme Verlag KG Stuttgart · New York
     
     
    Accuracy of endoscopic ultrasound elastography used for differential diagnosis of focal pancreatic masses: a multicenter study
     
    A.  Săftoiu1,2, P.  Vilmann2, F.  Gorunescu3, J.  Janssen4, M.  Hocke5, M.  Larsen6, J.  Iglesias-Garcia7, P.  Arcidiacono8, U.  Will9, M.  Giovannini10, C.  Dietrich11, R.  Havre12, C.  Gheorghe13, C.  McKay14, D.  I.  Gheonea1, T.  Ciurea1 , on behalf of the European EUS Elastography Multicentric Study Group
    1 Gastroenterology Department, University of Medicine and Pharmacy, Craiova, Romania
    2 Department of Surgical Gastroenterology, Gentofte and Herlev Hospital, University of Copenhagen, Denmark
    3 Biostatistics and Computer Science, University of Medicine and Pharmacy, Craiova, Romania
    4 Helios Klinikum, University of Witten/Herdecke, Wuppertal, Germany
    5 Department of Internal Medicine II, Hospital Meiningen, Germany
    6 Center for Surgical Ultrasound, Department of Surgery, Odense University Hospital, Odense, Denmark
    7 Gastroenterology, University Hospital, Santiago de Compostela, Spain
    8 Gastroenterology and Gastrointestinal Endoscopy Unit, Vita Salute San Raffaele University, Milan, Italy
    9 Gastroenterology, SRH Wald-Klinikum, Gera, Germany
    10 Endoscopic Unit, Paoli-Calmettes Institut, Marseilles, France
    11 Med. Klinik 2, Caritas-Krankenhaus Bad Mergentheim, Germany
    12 Institute of Medicine, University of Bergen and National Centre for Ultrasound in Gastroenterology, Haukeland University Hospital, Bergen, Norway
    13 Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Bucharest Romania
    14 Hepatobiliary Surgery, Glasgow Royal Infirmary, Glasgow, United Kingdom

    Background and study aims: Endoscopic ultrasound (EUS) elastography represents a new imaging procedure that might characterize the differences of hardness and strain between diseased tissue and normal tissue. The aim of this study was to assess the efficiency of EUS elastography for the differentiation of focal masses in chronic pancreatitis and pancreatic cancer.

    Patients and methods: The study group comprised 258 patients with focal pancreatic masses included prospectively at 13 participating centers. Qualitative analysis of the diagnoses made by two expert doctors using all recorded video clips was performed in order to test the interobserver variability. A post-processing software analysis was used to examine the EUS elastography videos by calculating average-hue histograms of individual elastography images. The quantitative information was used to calculate intra-observer variability and the accuracy of the method.

    Results: Qualitative analysis of the recorded videos revealed a kappa value of 0.72. Intra-observer variability analysis revealed that the single measure intraclass correlation ranged between 0.86 and 0.94. The average-hue histogram analysis of the data indicated a sensitivity of 93.4 %, a specificity of 66.0 %, a positive predictive value of 92.5 %, a negative predictive value of 68.9 %, and an overall accuracy of 85.4 %, based on a cut-off value of 175. Area under the receiver operating characteristic curve (AUROC) was 0.854 (P < 0.0001) with a confidence interval of 0.804 - 0.894.

    Conclusion: The value of quantitative analysis of EUS elastography recordings was proven by good reproducibility of the videos, as well as good parameters of the AUROC analysis. (Clinical Trials.gov identifier: CT00909103).

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