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基于探针的共聚焦激光显微内镜下的不确定性胰胆管狭窄的直接可视化:一个多中心实验

发布日期:2014-1-29 12:40:21 文章来源:GIE 作者次数:1288
    基于探针的共聚焦激光显微内镜下的不确定性胰胆管狭窄的直接可视化:一个多中心实验
     
    背景
    由于现行的内镜逆行胰胆管造影引导的组织抽样方法灵敏度低,所以难以治疗不确定性胰胆管狭窄患者。利用基于探针共聚焦激光显微内镜(pCLE)可以在进行内镜逆行胰胆管造影过程中实现狭窄实时微观可视化。
     
    目的
    记录并比较基于探针的共聚焦激光显微内镜与病理组织学实时诊断效果和性能以及其准确性。
     
    设计
    一项多中心登记机构内的前瞻性观察研究。
     
    环境
    五所学术研究中心
     
    患者
    这项研究涉及102例不确定性胰胆管狭窄患者。
     
    干预
    前瞻性收集相关的临床资料,内镜逆行胰胆管造影结果,组织抽查结果及基于探针的共聚焦激光显微内镜视屏。在获得病理结果前,要求研究人员在诊断过程中根据基于探针的共聚焦激光显微内镜提供一个假定诊断。对所有患者行至少30天随访,直到被明确诊断为恶性肿瘤,如果所示组织标本是良性,那么需1年的随访。
     
    主要测量指标
    与用组织获取内镜逆行胰胆管造影相比,内镜逆行胰胆管造影引导的基于探针的共聚焦激光显微内镜诊断的准确性,敏感性和特异性。
     
    结果
    在这项研究中,未发生与基于探针的共聚焦激光显微内镜相关的不良事件。有89例患者能被评估,其中40例被证实患有癌症。基于探针的共聚焦激光显微内镜用于检测癌性狭窄,其敏感性,特异性,阳性预测值,阴性预测值分别是98%, 67%, 71%, 97%,而指标病理学其值分别为45%, 100%, 100%, 69%。这导致基于探针的共聚焦激光显微内镜的总准确率为81%,而指标病理学为75%。内镜逆行胰胆管造影与基于探针的共聚焦激光显微内镜的联合使用使准确度显著高于利用组织获取的内镜逆行胰胆管造影(90% 比73%; P =0.001).。
     
    局限性
    调查人员已获得所有相关的临床信息,但这些信息可能使基于探针的共聚焦激光显微内镜预测特点有偏差。
     
    结论
    基于探针的共聚焦激光显微内镜提供了可靠的镜检而且它具有极好的灵敏度和阴性预测值。与利用组织获取的内镜逆行胰胆管造影相比,内镜逆行胰胆管造影和基于探针的共聚焦激光显微内镜具有较高的准确性,故可以用基于探针的共聚焦激光显微内镜辅助内镜逆行胰胆管造影。
     

    缩写词:CLE 共聚焦激光显微内镜,pCLE 基于探针的共聚焦激光显微内镜,NPV 阴性预测值,PPV 阳性预测值。

     

    Direct visualization of indeterminate pancreaticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience
     
    Background
    Because of the low sensitivity of current ERCP-guided tissue sampling methods, management of patients with indeterminate pancreaticobiliary strictures is a challenge. Probe-based confocal laser endomicroscopy (pCLE) enables real-time microscopic visualization of strictures during an ongoing ERCP.
    Objective
    To document the utility, performance, and accuracy of real-time pCLE diagnosis compared with histopathology.
    Design
    Prospective observational study within the framework of a multicenter registry.
    Setting
    Five academic centers.
    Patients
    This study involved 102 patients with indeterminate pancreaticobiliary strictures.
    Intervention
    Clinical information, ERCP findings, tissue sampling results, and pCLE videos were collected prospectively. Investigators were asked to provide a presumptive diagnosis based on pCLE during the procedure before pathology results were available. All patients received at least 30 days of follow-up until definitive diagnosis of malignancy was established or 1-year follow-up if index tissue sampling was benign.
    Main Outcome Measurements
    Diagnostic accuracy, sensitivity, specificity of ERCP-guided pCLE compared with ERCP with tissue acquisition.
    Results
    There were no pCLE-related adverse events in the study. We were able to evaluate 89 patients, of whom 40 were proven to have cancer. The sensitivity, specificity, positive-predictive value, and negative-predictive value of pCLE for detecting cancerous strictures were 98%, 67%, 71%, and 97%, respectively, compared with 45%, 100%, 100%, and 69% for index pathology. This resulted in an overall accuracy of 81% for pCLE compared with 75% for index pathology. Accuracy for combination of ERCP and pCLE was significantly higher compared with ERCP with tissue acquisition (90% vs 73%; P = .001).
    Limitations
    Investigators had access to all relevant clinical information, which may have biased the predictive characteristics of pCLE.
    Conclusion
    Probe-based CLE provides reliable microscopic examination and has excellent sensitivity and negative predictive value. The significantly higher accuracy of ERCP and pCLE compared with ERCP with tissue acquisition may support supplementing ERCP with pCLE.
    (作者:)
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