In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video)
In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video)
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DOI：
10.1016/j.gie.2013.09.020
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发表时间：
2014-02-01
影响因子：
7.7
通讯作者：
Kiesslich, Ralf
中科院分区：
文献类型：
--
作者：
Canto, Marcia Irene;Anandasabapathy, Sharmila;Kiesslich, Ralf
背景：共聚焦激光显微内镜（CLE）能够对胃肠道粘膜进行体内显微成像。然而，关于基于内窥镜的CLE（eCLE）用于Barrett食管（BE）成像的数据有限。目的：比较单独使用高清白光内窥镜（HDWLE）与随机活检（RB）和HDWLE + eCLE和靶向活检（TB）诊断BE肿瘤。设计：多中心、随机、对照试验。设置：学术医学中心。患者：干预：患者随机分为HDWLE + RB（第1组）或HDWLE + eCLE + TB（第2组）。实时诊断和管理计划记录后HDWLE在两组和后eCLE在第2组。盲法专家病理诊断的参考标准。主要结果测量：诊断率，性能特点，临床impacts.Results：共192例BE进行了研究。与HDWLE + RB相比，HDWLE + eCLE + TB导致粘膜活检数量减少，肿瘤诊断率更高（34% vs 7%; <0.0001），但准确性相当。HDWLE + eCLE + TB使肿瘤的诊断率增加了两倍（22% vs 6%; P = 0.002），并且可以避免65%患者的任何活检。在HDWLE中加入eCLE可将肿瘤检测的敏感性从40%提高到96%（P <0.0001），而特异性没有显著降低。在体内CLE改变了36%的patients.Limitations的治疗计划：三级保健转诊中心和专家内窥镜限制generalizability.Conclusion：实时eCLE和TB后HDWLE可以提高诊断率和准确性肿瘤和显着影响体内决策改变诊断和指导治疗。（临床试验注册号：NCT 01124214。）（Gastrointest Endosc 2014; 79：211-21.）
Background: Confocal laser endomicroscopy (CLE) enables in vivo microscopic imaging of the GI tract mucosa. However, there are limited data on endoscope-based CLE (eCLE) for imaging Barrett's esophagus (BE).Objective: To compare high-definition white-light endoscopy (HDWLE) alone with random biopsy (RB) and HDWLE + eCLE and targeted biopsy (TB) for diagnosis of BE neoplasia.Design: Multicenter, randomized, controlled trial.Setting: Academic medical centers.Patients: Adult patients with BE undergoing routine surveillance or referred for early neoplasia.Intervention: Patients were randomized to HDWLE + RB (group 1) or HDWLE + eCLE + TB (group 2). Real-time diagnoses and management plans were recorded after HDWLE in both groups and after eCLE in group 2. Blinded expert pathology diagnosis was the reference standard.Main Outcome Measurements: Diagnostic yield, performance characteristics, clinical impact.Results: A total of 192 patients with BE were studied. HDWLE + eCLE + TB led to a lower number of mucosal biopsies and higher diagnostic yield for neoplasia (34% vs 7%; < .0001), compared with HDWLE + RB but with comparable accuracy. HDWLE + eCLE + TB tripled the diagnostic yield for neoplasia (22% vs 6%; P = .002) and would have obviated the need for any biopsy in 65% of patients. The addition of eCLE to HDWLE increased the sensitivity for neoplasia detection to 96% from 40% (P < .0001) without significant reduction in specificity. In vivo CLE changed the treatment plan in 36% of patients.Limitations: Tertiary-care referral centers and expert endoscopists limit generalizability.Conclusion: Real-time eCLE and TB after HDWLE can improve the diagnostic yield and accuracy for neoplasia and significantly impact in vivo decision making by altering the diagnosis and guiding therapy. (Clinical trial registration number: NCT01124214.) (Gastrointest Endosc 2014; 79:211-21.)