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Barrett 食管中胃肠道肿瘤的黏膜消融或切除术后对残留上皮化生行共聚焦激光显微内镜评估的多中心、

发布日期:2014-1-29 12:40:50 文章来源: 作者次数:3340
    Barrett 食管中胃肠道肿瘤的黏膜消融或切除术后对残留上皮化生行共聚焦激光显微内镜评估的多中心、随机对照试验

    20121月收到;201252批准;201272出版。

    背景

    内镜下消融术是一种公认的治疗Barrett食管(BE)肿瘤的标准手段。但不可能在内镜下准确地确定所有远端食管的腺体黏膜的根治。

    目的

    除了高清晰度白光(HDWL),使用基于探针的共聚焦激光显微内镜(pCLE)是否有助于测定残留的BE,对此我们进行了评估。

    设计

    前瞻性、多中心、随机临床试验。

    环境

    学术医疗中心。

    患者

    接受消融治疗的Barrett 食管患者。

    干预

    初次尝试消融后,采用HDWL内镜检查或HDWLpCLE 对患者进行随访,并基于内镜结果和用于避免过度治疗的pCLE对残留上皮化生或肿瘤进行治疗。

    主要测量指标

    最佳治疗的患者比例,定义为携带残留BE的接受过治疗且接受完全消融术的患者,以及那些未接受治疗而且在随访时未发现疾病迹象的患者。

    患者

    根据先验标准,在计划中期分析时终止该研究。患者纳入终止后,将患者随机化分组,然后完成研究。在进行随访的119例患者中,两组达到最佳疗效的患者比例无差异(15/57 26%的患者接受HDWL17/6227%的患者接受 HDWL + pCLE)。两组中其它疗效相似。

    局限性
    因两组间差异缺乏所致的条件力量较低,所以中期分析后终止该研究,同时,两组中残留的Barrett 食管高于预期。

    结论

    该研究不能表明, 对于残留的Barrett 食管或肿瘤检测,HDWL 成像加pCLE可提供更好的治疗。(临床试验注册号:NCT01032044。)

    缩写词BEBarrett食管;GM,胃上皮化生;HDWL,高清晰度的白色光;HGD,高度不典型增生;HGN,高度肿瘤;IM,肠上皮化生;LGD,低度不典型增生;LGN,低度肿瘤;pCLE,基于探针的共聚焦激光显微内镜;RFA,射频消融术。


     

    Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus

    Received 9 January 2012; accepted 2 May 2012. published online 02 July 2012.

    Background

    Endoscopic ablation is an accepted standard for neoplasia in Barrett's esophagus (BE). Eradication of all glandular mucosa in the distal esophagus cannot be reliably determined at endoscopy.

    Objective

    To assess if use of probe-based confocal laser endomicroscopy (pCLE) in addition to high-definition white light (HDWL) could aid in determination of residual BE.

    Design

    Prospective, multicenter, randomized, clinical trial.

    Setting

    Academic medical centers.

    Patients

    Patients with Barrett's esophagus undergoing ablation.

    Intervention

    After an initial attempt at ablation, patients were followed-up either with HDWL endoscopy or HDWL plus pCLE, with treatment of residual metaplasia or neoplasia based on endoscopic findings and pCLE used to avoid overtreatment.

    Main Outcome Measurements

    The proportion of optimally treated patients, defined as those with residual BE who were treated and had complete ablation plus those without BE who were not treated and had no evidence of disease at follow-up.

    Results

    The study was halted at the planned interim analysis based on a priori criteria. After enrollment was halted, all patients who had been randomized were followed to study completion. Among the 119 patients with follow-up, there was no difference in the proportion of patients achieving optimal outcomes in the two groups (15/57, 26% for HDWL; 17/62, 27% with HDWL + pCLE). Other outcomes were similar in the two groups.

    Limitations

    The study was closed after the interim analysis due to low conditional power resulting from lack of difference between groups as well as higher-than-expected residual Barrett's esophagus in both arms.

    Conclusion

    This study yields no evidence that the addition of pCLE to HDWL imaging for detection of residual Barrett's esophagus or neoplasia can provide improved treatment. (Clinical trial registration number: NCT01032044.)

    Abbreviations:  BE, Barrett's esophagus, GM, gastric metaplasia, HDWL, high-definition white light, HGD, high-grade dysplasia, HGN, high-grade neoplasia, IM, intestinal metaplasia, LGD, low-grade dysplasia, LGN, low-grade neoplasia, pCLE, probed-based confocal laser endomicroscopy, RFA, radiofrequency ablation

     

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