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利用探针型共聚焦激光显微內镜实时增加对Barrett食管肿瘤组织的检测一项国际性的多中心前瞻性随机对

发布日期:2014-1-29 12:40:20 文章来源:GIE 作者次数:1170
    利用探针型共聚焦激光显微内镜实时增加对Barrett食管肿瘤组织的检测:一项国际性的多中心前瞻性随机对照试验
    背景
    探针型共聚焦激光显微內镜(pCLE)允许对Barret食管肿瘤组织(BE)实施实时检测。然而迄今为止还未对探针型共聚焦激光显微內镜(pCLE)实时检测方面的准确度进行广泛评估。
    目的
    比较pCLE(探针型共聚焦激光显微內镜)结合高清晰度白光內镜检查(HD-WLE)与单独使用HD-WLE(高清晰度白光內镜检查术)检测Barret食管(BE)高度发育异常和早期癌的敏感性和特异性。
    设计
    国际性的前瞻性、多中心、随机控制试验。
    环境
    五所三级转诊中心。
    患者
    共101例连续性BE患者准备接受HGD/EC的检测或內镜治疗。
    干预
    所有患者都通过HD-WLE高清晰度白光內镜检查术)、窄带成像內镜(NBI)和pCLE(探针型共聚焦激光显微內镜)检测,而且我们在取得活检标本之前记录所有的发现情况。由两位独立的事先不知情的内径师实施HD-WLE和NBI,且实施顺序是随机的。记载有关HD-WLE (高清晰度白光內镜检查术)或NBI(窄带成像內镜)和四象限随机位置的所有疑似病变。这些位置是由pCLE探针型共聚焦激光显微內镜)来检测的,且对良性或肿瘤(HGD/EC)组织实时进行一项初步诊断。最后对所有病变位置实施活检,并由一位重要的对內镜检查和pCLE(探针型共聚焦激光显微內镜)数据不了解的病理学家进行评估。
    主要结果测量
    pCLE探针型共聚焦激光显微內镜)诊断特性
    结果
    HD-WLE高清晰度白光內镜检查术)的敏感性和特异性分别为34.2%和92.7%,相比较下,HD-WLE 或 pCLE的敏感性和特异性分别为68.3%和87.8%(P = 0.002,P < 0.001)。HD-WLE或NBI的敏感性和特异性分别为45.0%和88.2%,相比较下,HD-WLE,,NBI或pCLE的敏感性和特异性分别为75.8%和84.2%(P分别为0.01和0.02)。pCLE 、HD-WLE和NBI联合使用与单独使用HD-WLE,HD-WLE或NBI二者相比,能够分别多确认2个,1个高度发育异常/早期癌(HGD/EC)患者,这样就会使所有高度发育异常/早期癌(HGD/EC)患者都被检测到,但是这些数据没有统计学意义。
    局限性
    有着大量人口的学术中心。
    结论
    pCLE(探针型共聚焦激光显微內镜)与HD-WLE(高清晰度白光內镜检查术)联合治疗与使用HD-WLE相比,可显著提高对Barret食管(BE)患者肿瘤的检测效能。这为BE患者管理和后续治疗作出更明智的决策提供了可能性。
     
    缩写词:BE为Barretts食管,CLE为共聚焦显微内镜,EC为早期癌,HD-WLE为高清晰度白光內镜检查术,HGD为高度发育异常LGD为低度发育异常,NBI为窄带成像,NPV为阴性预测值,pCLE为探针型共聚焦显微内镜。
     
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    Real-time increased detection of neoplastic tissue in Barretts esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial

    Background
    Probe-based confocal laser endomicroscopy (pCLE) allows real-time detection of neoplastic Barretts esophagus (BE) tissue. However, the accuracy of pCLE in real time has not yet been extensively evaluated.
    Objective
    To compare the sensitivity and specificity of pCLE in addition to high-definition white-light endoscopy (HD-WLE) with HD-WLE alone for the detection of high-grade dysplasia (HGD) and early carcinoma (EC) in BE.
    Design
    International, prospective, multicenter, randomized, controlled trial.
    Setting
    Five tertiary referral centers.
    Patients
    A total of 101 consecutive BE patients presenting for surveillance or endoscopic treatment of HGD/EC.
    Interventions
    All patients were examined by HD-WLE, narrow-band imaging (NBI), and pCLE, and the findings were recorded before biopsy samples were obtained. The order of HD-WLE and NBI was randomized and performed by 2 independent, blinded endoscopists. All suspicious lesions on HD-WLE or NBI and 4-quadrant random locations were documented. These locations were examined by pCLE, and a presumptive diagnosis of benign or neoplastic (HGD/EC) tissue was made in real time. Finally, biopsies were taken from all locations and were reviewed by a central pathologist, blinded to endoscopic and pCLE data.
    Main Outcome Measurements
    Diagnostic characteristics of pCLE.
    Results
    The sensitivity and specificity for HD-WLE were 34.2% and 92.7%, respectively, compared with 68.3% and 87.8%, respectively, for HD-WLE or pCLE (P = .002 and P < .001, respectively). The sensitivity and specificity for HD-WLE or NBI were 45.0% and 88.2%, respectively, compared with 75.8% and 84.2%, respectively, for HD-WLE, NBI, or pCLE (P = .01 and P = .02, respectively). Use of pCLE in conjunction with HD-WLE and NBI enabled the identification of 2 and 1 additional HGD/EC patients compared with HD-WLE and HD-WLE or NBI, respectively, resulting in detection of all HGD/EC patients, although not statistically significant.
    Limitations
    Academic centers with enriched population.
    Conclusions
    pCLE combined with HD-WLE significantly improved the ability to detect neoplasia in BE patients compared with HD-WLE. This may allow better informed decisions to be made for the management and subsequent treatment of BE patients. (Clinical trial registration number: NCT00795184.)
    Abbreviations: BE, Barretts esophagus, CLE, confocal laser endomicroscopy, EC, early carcinoma, HD-WLE, high-definition white-light endoscopy, HGD, high-grade dysplasia, LGD, low-grade dysplasia, NBI, narrow-band imaging, NPV, negative predictive value, pCLE, probe-based confocal laser endomicroscopy
     
     
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