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在超声内镜引导下细针穿刺期间采用探针和未采用探针所致的恶性肿瘤诊断率:一项前瞻性的单盲随机对照试验

发布日期:2014-1-29 12:40:49 文章来源:GIE 作者次数:1541
    2012227收到,2012323批准,2012614网上发布。

    背景

    一般认为,在内镜超声引导下的细针穿刺(EUS-FNA)期间使用探针可提高标本质量和诊断率。

    目的

    比较在采用探针(S+)和不使用探针(S−)情况下内镜超声引导下细针穿刺所得样本,以了解所得样本的恶性疾病的诊断率和细胞学特征。

    设计

    随机对照试验。

    环境

    三级转诊中心。

    患者

    接受超声内镜引导下的细针穿刺治疗实性病变的患者。

    干预

    超声内镜下引导的细针穿刺;经病变部位确定穿刺次数(6 例患者的胰腺/其它和4例淋巴结)。

    主要测量指标

    恶性疾病的诊断率和细胞结构程度,样本充足性,污染情况和血液量。

    结果

    这项随机对照研究共纳入100例患者,超声内镜引导下的细针穿刺部位为胰腺(58例)和淋巴结(25)以及其它(17)。诊断为恶性肿瘤56例,良性30例,疑似/非典型7例,而且7例患者的样本不充足。共进行了550次穿刺(采用探针进行了275次,未采用探针进行了275次)。中期分析表明,在恶性肿瘤诊断率(采用探针进行了94次穿刺[34.2%],未采用探针进行了110[40%]P = 0.2)和不充足样本的比例(采用探针的有57[20.7%],不采用探针的有64[23.3%]P =0 .2)方面,二者的差异均不显著。细胞结果(P = 0.83),污染情况(P =0 .31),细胞数(P =0 .25)和血液量(P =0 .6)之间均无差异。根据病变部位,我们在亚组分析中发现相似的结果。所以应用这些无意义的规则,我们终止了这项研究。

    局限性

    细胞病理学家评估时的主观性,内镜超声技师在知情的情况下进行检查。

    结论

    在采用探针和未采用探针穿刺两组中,所得的恶性肿瘤诊断率或不充足样本比例没有差异。这些结果表明,在超声内镜引导下的细针穿刺期间,使用探针不会带来任何优势。(临床试验注册编号:NCT01316614。)

    缩写词:EUS-FNA,内镜超声下引导的细针穿刺;SD,标准偏差。

     


    Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: a prospective, single blind, randomized, controlled trial

    Presented at Digestive Disease Week, San Diego,California, 2012 (Gastrointestinal Endosc 2012;75:AB128-9).

    Received 27 February 2012; accepted 23 March 2012. published online 14 June 2012.

    Background

    Use of a stylet during EUS-guided FNA (EUS-FNA) is believed to improve the quality and diagnostic yield of specimens.

    Objective

    To compare samples obtained by EUS-FNA with (S+) and without (S−) a stylet for diagnostic yield of malignancy and cytological characteristics.

    Design

    Randomized, controlled trial.

    Setting

    Tertiary referral center.

    Patients

    Consecutive patients referred for EUS-FNA of solid lesions.

    Intervention

    EUS-FNA; the number of passes was determined by lesion site (6 pancreas/others and 4 lymph nodes).

    Main Outcome Measurements

    Diagnostic yield of malignancy and degree of cellularity, specimen adequacy, contamination, and amount of blood.

    Results

    One hundred patients were prospectively enrolled in this randomized, controlled trial and the sites of EUS-FNA were the pancreas, 58; lymph node, 25; and other, 17. The overall diagnosis was malignancy in 56, benign in 30, suspicious/atypical in 7, and inadequate specimen in 7 lesions. There were 550 passes made (275 with a stylet and 275 without a stylet). Interim analysis demonstrated no difference in the diagnostic yield of malignancy (94 passes with a stylet [34.2%] vs 110 without a stylet [40%], P = .2) and in the proportion of inadequate specimens (57 with a stylet [20.7%] vs 64 without a stylet [23.3%], P = .2). There was no difference with regard to cellularity (P = .83), contamination (P = .31), number of cells (P = .25), and amount of blood (P = .6). Similar results were noted in a subgroup analysis based on lesion site. Applying the rules of futility, the study was terminated.

    Limitations

    Subjectivity in cytopathologists' assessment, endosonographer not blinded.

    Conclusions

    There was no difference in the diagnostic yield of malignancy or proportion of inadequate specimens between passes with and without a stylet. These results suggest that the use of a stylet does not confer any advantage during EUS-FNA. (Clinical trial registration number: NCT01316614.)

    Abbreviations:  EUS-FNA, EUS-guided FNA, SD, standard deviation

     

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