Endoscopy Unit, Ospedale Nuovo Regina Margherita, Rome, Italy.
AOU Città della Salute e della Scienza, CPO Piemonte, Turin, Italy.
Gastrointest Endosc. 2019 Mar;89(3):583-590.e1. doi: 10.1016/j.gie.2018.10.019. Epub 2018 Oct 24.
The EndoRings add-on has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty about their correspondence. The aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia.
Consecutive patients undergoing colonoscopy after a positive fecal immunochemical test (FIT) within an organized screening program in 7 Italian centers were randomized between a parallel (EndoRings or standard) or a crossover (EndoRings/standard or standard/EndoRings) methodology. Outcomes measures were the adenoma detection rate (ADR) and advanced adenoma detection rate (AADR) in the parallel arms and the miss rate of adenomas in the crossover arms.
Of 958 eligible patients, 927 (317 EndoRings; 317 standard; 142 EndoRings/standard; 151 standard/Endo-Rings) were included in the final analysis. In the parallel arms (mean ADR, 51.3%; mean AADR, 25.4%), no difference between standard and EndoRings was found for both ADR (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28) and AADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings, 1.9 ± 1.3 and 1.0 ± 1.2; standard, 2.1 ± 1.5 and 1.0 ± 1.2; P = not significant for both comparisons). In the crossover arms, no difference in the miss rate for adenomas between EndoRings and standard was found at per polyp (RR, 1.43; 95% CI, 0.97-2.10) or per-patient analysis (24% vs 26%; P = .76).
No statistically significant difference in diagnostic yield and miss rate between EndoRings and standard colonoscopy was detected in patients with a positive FIT result. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship. (ISRCTN registry: ISRCTN10357435.).
EndoRings 附加装置据称可提高结肠镜检查中腺瘤的检出率，但现有数据并不一致。在测试新技术时，平行和交叉方法学测量不同的结果，这使得它们之间的对应关系存在不确定性。本研究旨在比较 EndoRings 对结直肠肿瘤的诊断效果和腺瘤漏诊率。
在意大利 7 家中心的一项有组织的筛查计划中，对经粪便免疫化学试验（FIT）阳性的连续患者进行结肠镜检查，将其随机分为平行（EndoRings 或标准）或交叉（EndoRings/标准或标准/EndoRings）方法学组。主要观察终点是平行组的腺瘤检出率（ADR）和高级别腺瘤检出率（AADR），交叉组的腺瘤漏诊率。
在 958 例符合条件的患者中，927 例（317 例接受 EndoRings 治疗；317 例接受标准治疗；142 例接受 EndoRings/标准治疗；151 例接受标准/EndoRings 治疗）被纳入最终分析。在平行组（平均 ADR，51.3%；平均 AADR，25.4%）中，标准组和 EndoRings 组的 ADR（相对风险 [RR]，1.10；95%置信区间 [CI]，0.95-1.28）和 AADR（RR，1.16；95%CI，0.88-1.51）均无差异，每位患者的平均腺瘤和高级别腺瘤数量也无差异（EndoRings 组，1.9±1.3 和 1.0±1.2；标准组，2.1±1.5 和 1.0±1.2；P 均无显著差异）。在交叉组中，EndoRings 组和标准组在每枚息肉（RR，1.43；95%CI，0.97-2.10）或每位患者（24%比 26%；P=.76）的腺瘤漏诊率方面无统计学差异。
在经 FIT 检测阳性的患者中，EndoRings 与标准结肠镜检查的诊断效果和腺瘤漏诊率之间未发现统计学显著差异。漏诊率和检出率之间显示出有临床意义的相关性，支持因果关系。（ISRCTN 注册：ISRCTN81374404。）
