Background and Aims

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.

Methods

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.

Results

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).

Conclusions

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.)

中文翻译：

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一项有组织的大肠癌筛查计划中EndoRings的诊断率和漏诊率：SMART（ADR相关技术研究方法）试验

背景和目标

EndoRings附加组件已被宣称可以改善结肠镜检查中的腺瘤检测，但是可用数据并不一致。在测试一项新技术时，并行和交叉方法会测量不同的结果，因此不确定它们的对应关系。这项研究的目的是比较EndoRings对结直肠肿瘤的诊断率和漏诊率。

方法

在意大利7个中心的有组织筛查程序中，对接受粪便免疫化学测试（FIT）阳性的连续患者进行结肠镜检查，将他们随机分为平行方法（EndoRings或标准）或交叉方法（EndoRings / standard或standard / EndoRings）方法。结局指标为平行臂的腺瘤检出率（ADR）和晚期腺瘤检出率（AADR）以及交叉臂的腺瘤漏诊率。

结果

在958名合格患者中，有927名患者（317名EndoRings； 317名标准； 142名EndoRings / Standard； 151名标准/ Endo-Rings）被纳入最终分析。在平行治疗组中（平均ADR，51.3％；平均ADR，25.4％），两种ADR的标准剂量和EndoRings均无差异（相对风险[RR]为1.10； 95％置信区间[CI]为0.95-1.28）和AADR（RR，1.16； 95％CI，0.88-1.51），以及每位患者的平均腺瘤和晚期腺瘤数目（EndoRings，1.9±1.3和1.0±1.2；标准，2.1±1.5和1.0±1.2 ；P  =两次比较均不显着）。在交叉臂中，在每个息肉（RR，1.43； 95％CI，0.97-2.10）或按患者分析（24％vs 26％；P  = 0）下，EndoRings与标准品之间的腺瘤漏诊率没有差异。 76）。

结论

FIT结果为阳性的患者在EndoRings与标准结肠镜检查之间的诊断产率和漏诊率没有统计学上的显着差异。显示了漏检率和检出率之间的临床相关性，支持了因果关系。（ISRCTN注册表：ISRCTN10357435。）