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比较用于内镜超声引导下对实性胰腺肿块取样的22G抽吸针和22G活检针的随机试验

发布日期:2014-1-29 12:40:48 文章来源:GIE 作者次数:1585
    2012128收到,2012320批准,201264网上发布。

    背景

    为克服细胞学的局限性,活检针已发展到能够在超声内镜检查期间获取组织学标本的地步。

    目的

    比较用于内镜超声引导下对实性胰腺肿块取样的22号(G)细针抽吸针和22G活检针(FNB)。

    设计

    随机试验。

    环境

    三级医疗中心。

    患者

    本研究包括56例实性胰腺肿块患者。

    局限性

    采用22 G细针抽吸或22 G 细针活检设备对胰腺肿块进行取样。

    主要测量指标

    比较需达到诊断要求的中位穿刺数、诊断所需样本充足性、技术性能、并发症发生率、组织学核心样本取得和组织学样本质量。

    结果

    28例患者分别被随机分配到FNA组和FNB组。FNAFNB针所需达到诊断要求的穿刺中位数(1[四分位范围为:1-2.5])与1[四分位范围为:1-1]P =0 .21)、诊断充足性(100%89.3%P =0 .24)、技术故障(03.6%P = 1.0)或并发症(均为3.6%)均无显著差异。FNAFNB队列中仅需1次穿刺就达到诊断要求的患者比例分别为64.3%67.9%,需23次穿刺达到诊断要求的患者比例分别为10.7%17.9%以及25%3.6%。同时两队列之间的组织学核心样本取得(100% 83.3%P = 0.26)或诊断组织学样本的取得(66.7% 80%P =0.66)均无显著差异。

    局限性

    仅评估胰腺肿块。

    结论

    在诊断所需样本充足性、技术性能和安全性方面,FNAFNB针具有可比性。而且2种类型的针所得组织学核心样本产量或质量之间不存在显著差异。(临床试验注册号:NCT01394159

    缩写词:EUS-FNA,超声内镜引导下的细针穿刺术;FNB,细针活检;HBSSHank 缓冲盐溶液;TNBTrucut 穿刺活检。

     


    Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions

    Received 28 January 2012; accepted 20 March 2012. published online 04 June 2012

    Background

    To overcome limitations of cytology, biopsy needles have been developed to procure histologic samples during EUS.

    Objective

    To compare 22-gauge (G) FNA and 22Gbiopsy needles (FNB) for EUS-guided sampling of solid pancreatic masses.

    Design

    Randomized trial.

    Setting

    Tertiary-care medical center.

    Patients

    This study involved 56 patients with solid pancreatic masses.

    Intervention

    Sampling of pancreatic masses by using22GFNA or22GFNB devices.

    Main Outcome Measurements

    Compare the median number of passes required to establish the diagnosis, diagnostic sufficiency, technical performance, complication rates, procurement of the histologic core, and quality of the histologic specimen.

    Results

    A total of 28 patients were randomized to the FNA group and 28 to the FNB group. There was no significant difference in median number of passes required to establish the diagnosis (1 [interquartile range 1-2.5] vs 1 [interquartile range 1-1]; P = .21), rates of diagnostic sufficiency (100% vs 89.3%; P = .24), technical failure (0 vs 3.6%; P = 1.0), or complications (3.6% for both) between FNA and FNB needles, respectively. Patients in whom diagnosis was established in passes 1, 2, and 3 were 64.3% versus 67.9%, 10.7% versus 17.9%, and 25% versus 3.6%, respectively, for FNA and FNB cohorts. There was no significant difference in procurement of the histologic core (100% vs 83.3%; P = .26) or the presence of diagnostic histologic specimens (66.7% vs 80%; P = .66) between FNA and FNB cohorts, respectively.

    Limitations

    Only pancreatic masses were evaluated.

    Conclusion

    Diagnostic sufficiency, technical performance, and safety profiles of FNA and FNB needles are comparable. There was no significant difference in yield or quality of the histologic core between the 2 needle types. (Clinical trial registration number: NCT01394159.)

    Abbreviations:  EUS-FNA, EUS-guided FNA, FNB, fine-needle biopsy, HBSS, Hank buffered salt solution, TNB, Trucut needle biopsy

     

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