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比较22G与25G细针应用于內镜超声引导下细针穿刺活检术诊断实性病变的随机临床试验

发布日期:2014-1-29 12:40:16 文章来源:Endoscopy 作者次数:1153
    比较22G与25G细针应用于內镜超声引导下细针穿刺活检术诊断实性病变的随机临床试验
     
    L.  Camellini1, G.  Carlinfante2, F.  Azzolini1, V.  Iori1, M.  Cavina1, G.  Sereni1, F.  Decembrino1, C.  Gallo2, I.  Tamagnini2, R.  Valli2, S.  Piana2, C.  Campari3, G.  Gardini2, R.  Sassatelli1  
    1 意大利雷焦艾米利亚Santa Maria Nuova医院胃肠病学和消化内镜单位
    2意大利雷焦艾米利亚Santa Maria Nuova医院病理学单位
    3意大利AUSL雷焦艾米利亚公共健康系
     
    背景与研究目的:
        本研究目的是调查在细针在內镜超声引导下细针穿刺活检(EUS-FNA) 诊断实性病变时,所使用的25G针是否优于22G 细针。
     
    患者和方法:
        本研究是一项单中心随机临床试验。手术环境为一所三级转诊医院,在这里进行內镜超声引导下细针穿刺活检(EUS-FNA) 诊断实性病变,并有一位对针尺寸不了解的细胞病理学家现场协助。主要目标得分是为获取充分样品而实施的穿刺次数。如果穿刺5次都不成功或者胃肠学家穿刺病变组织有困难,那么可以更换另一类型针。
     
    结果:
        共129处实性病变被随机分为22G与25G两组,并对127处病变数据进行分析。结果发现:在使用22G针组中平均穿刺次数为3.7 (± 1.9),而在25G针组中平均次数为3.8 (± 2),其中两组平均数相差0.1,95%置信区间CI为- 0.59-0.79;在22G组中,共取的样品为63,而有58(92.1%)是充足的,而在25G组中,共取的样品为63,有60处(93.7%)是充足的,两组样品比例差别为-1.6 %,95 %置信区间CI为- 12.1 %-8.9 %;25G、22G两组中分别有11、12处使用了另一型号针,分别占总数63、64的17.5%、18.7%,差别为- 1.2 %,95 %置信区间CI为 - 16.2 %-13.8 %。将22G更换为25G细针后成功穿刺4处钩突包块,而这些病变很难用22G穿刺成功。
     
    结论:
        本研究未能说明25G在內镜超声引导下细针穿刺活检(EUS-FNA)时比22G更有效,然而使用25G细针更易成功刺中远端病变。
     
     
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    A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions
     
    L.  Camellini1, G.  Carlinfante2, F.  Azzolini1, V.  Iori1, M.  Cavina1, G.  Sereni1, F.  Decembrino1, C.  Gallo2, I.  Tamagnini2, R.  Valli2, S.  Piana2, C.  Campari3, G.  Gardini2, R.  Sassatelli1
    1 Unit of Gastroenterology and Digestive Endoscopy, Santa Maria Nuova Hospital, Reggio Emilia, Italy
    2 Unit of Pathology, Santa Maria Nuova Hospital, Reggio Emilia, Italy
    3 Department of Public Health, AUSL Reggio Emilia, Italy
     
    Background and study aims: The study aimed to investigate whether the 25G needle is superior to the 22G needle when used in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of solid lesions.
     
    Patients and methods: The study was a single-center randomized clinical trial. The setting was a tertiary referral hospital, where EUS-FNA of solid lesions was assisted by an on-site cytopathologist, who was blinded to the needle size. The main end point was the number of passes performed to obtain adequate samples. Crossover to the other type of needle was allowed after five passes, or when the gastroenterologist experienced difficulties in puncturing the lesions.
     
    Results: A total of 129 solid lesions were randomized and data regarding 127 lesions were analyzed. The mean number of passes was 3.7 (± 1.9) in the 22G needle group and 3.8 (± 2) in the 25G needle groups (difference of means: 0.1; 95 %CI: - 0.59 to 0.79). Fifty-eight of 63 (92.1 %) and 60/64 samples (93.7 %) in the 22G and 25G needle groups respectively were adequate (difference: - 1.6 %; 95 %CI: - 12.1 % to 8.9 %). Crossover to the other type of needle was performed in 11/63 (17.5 %) and in 12/64 (18.7 %) lesions in the two groups respectively (difference: - 1.2 %; 95 %CI: - 16.2 % to 13.8 %). A crossover to the 25G needle was successfully performed in four masses in the uncinate process; these lesions were difficult to puncture using the 22G needle.
     
    Conclusions: Our study failed to demonstrate that the 25G is more effective than the 22G needle in EUS-FNA of solid lesions. However, targeting of lesions in the distal duodenum may be simplified by using the 25G needle.
     
     
     
     
     
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