Multicenter, randomized, tandem evaluation of EndoRings colonoscopy - results of the CLEVER study
Multicenter, randomized, tandem evaluation of EndoRings colonoscopy - results of the CLEVER study
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DOI：
10.1055/s-0034-1392421
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发表时间：
2015-12-01
期刊：
影响因子：
9.3
通讯作者：
Siersema, Peter D.
中科院分区：
文献类型：
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作者：
Dik, Vincent K.;Gralnek, Ian M.;Siersema, Peter D.
背景和研究目的：结肠镜检查中腺瘤漏诊率已成为结肠镜检查后结直肠癌的一个广泛认可的替代指标。除其他原因外，这可能是由于结肠褶皱和弯曲的近端方面的可视化不足而发生的。EndoRings（EndoAid Ltd.，凯撒利亚，以色列）是一种安装在结肠镜远端的硅橡胶装置。其灵活的圆环在撤回过程中接合并机械拉伸结肠褶皱。本研究的主要目的是比较腺瘤错过率之间的标准结肠镜检查和结肠镜检查使用EndoRings.Methods：在这个多中心，随机，串联结肠镜检查研究，我们进行了同一天，背靠背结肠镜检查EndoRings其次是标准结肠镜检查，反之亦然。结果：在排除10例方案违背患者后，116例患者（38.8%女性;平均年龄58.7岁）仍用于分析。EndoRings结肠镜检查的腺瘤漏诊率（7/67; 10.4%）明显低于标准结肠镜检查（28/58; 48.3%）（P < 0.001）。息肉漏诊率的结果相似：EndoRings（9.1%）和标准结肠镜检查（52.8%; P < 0.001）。EndoRings和标准结肠镜检查的平均盲肠插管时间（9.3 vs. 8.4分钟; P = 0.142）和拔管时间（7.4 vs. 7.2分钟; P = 0.286）无显著差异。EndoRings的平均总手术时间长于标准结肠镜检查（21.6 vs. 18.5分钟，P = 0.001），因为切除了更多的息肉。结论：本研究表明，EndoRings结肠镜检查的腺瘤和息肉漏诊率低于标准结肠镜检查，这可能会提高筛查和监测结肠镜检查的有效性。
Background and study aims: Adenoma miss rate during colonoscopy has become a widely acknowledged proxy measure for post-colonoscopy colorectal cancer. Among other reasons, this can happen because of inadequate visualization of the proximal aspects of colonic folds and flexures. EndoRings (EndoAid Ltd., Caesarea, Israel) is a silicone-rubber device that is fitted onto the distal end of the colonoscope. Its flexible circular rings engage and mechanically stretch colonic folds during withdrawal. The primary aim of this study was to compare adenoma miss rates between standard colonoscopy and colonoscopy using EndoRings.Methods: In this multicenter, randomized, tandem colonoscopy study, we performed same-day, back-to-back colonoscopies with EndoRings followed by standard colonoscopy, or vice versa. Results: After exclusion of 10 patients for protocol violations, 116 patients (38.8% female; mean age 58.7) remained for analysis. The adenoma miss rate of EndoRings colonoscopy (7/67; 10.4 %) was significantly lower (P < 0.001) compared with standard colonoscopy (28/58; 48.3 %). Similar results were found for polyp miss rates: EndoRings (9.1 %) and standard colonoscopy (52.8 %; P < 0.001). Mean cecal intubation times (9.3 vs. 8.4 minutes; P = 0.142) and withdrawal times (7.4 vs. 7.2 minutes; P = 0.286), respectively, were not significantly different between EndoRings and standard colonoscopy. Mean total procedure time was longer with EndoRings than with standard colonoscopy (21.6 vs. 18.5 minutes, P = 0.001) as more polyps were removed.Conclusions: This study demonstrates that colonoscopy with EndoRings has lower adenoma and polyp miss rates than standard colonoscopy, which may improve the efficacy particularly of screening and surveillance colonoscopies.