Jaensch Claudia, Jepsen Mogens Harrits, Christiansen David Høyrup, Madsen Anders Husted, Madsen Mogens Rørbæk
Surgical Research Department, Regional Hospital West Jutland, Gl. Landevej 61, 7400, Herning, Denmark.
Department of Endoscopy, Regional Hospital West Jutland, Herning, Denmark.
Surg Endosc. 2022 Sep;36(9):1-9. doi: 10.1007/s00464-022-09049-5. Epub 2022 Feb 9.
Adenoma detection rate (ADR) is the single most important measure of quality in colonoscopy, but little is known about the detection rate of serrated lesions (SLDR). To improve ADR, Endocuff Vision (EV) can be used. Studies have shown differing results as to the effect on ADR; an effect on SLDR has not been shown. To investigate the effect of Endocuff Vision on ADR in a screening population, this randomized controlled open label trial with concealed allocation was performed. Randomization to trial group was carried out by the endoscopist using prepared numbered envelopes.
Patients referred as part of the national bowel screening program at Regional Hospital Herning, Denmark were recruited and allocated to one of two groups: Endocuff Vision colonoscopy (EVC) and standard colonoscopy (SC). Outcomes were ADR, mean number, site, and size of lesions per procedure. SLDR as outcome was added after inclusion had begun.
A total of 1178 participants were included, with 1166 (EVC 583 and SC 583) available for analysis. There was no clinical relevant difference in ADR (59.2% [CI 55.1; 63.1] v 60.5% [CI 56.5; 64.4]) or SLDR (13.0% [CI 10.5; 16.0] v 10.3% [CI 8.0; 13.0]) between groups. More serrated lesions were found per procedure (MSP) (0.2 v 0.1, IRR 57% [CI 17; 109]. Removal rate of EV was similar in the two study groups.
We found no significant effects of the use of Endocuff Vision on ADR, when compared to standard colonoscopy, but more serrated lesions were detected in the Endocuff group.
Clinical Trials NCT04651062.
腺瘤检出率(ADR)是结肠镜检查质量的最重要单一指标,但关于锯齿状病变检出率(SLDR)的了解却很少。为提高ADR,可使用Endocuff Vision(EV)。关于其对ADR的影响,研究结果各异;尚未显示其对SLDR有影响。为研究Endocuff Vision对筛查人群ADR的影响,开展了这项采用隐蔽分组的随机对照开放标签试验。由内镜医师使用预先准备好的编号信封将患者随机分配至试验组。
招募丹麦海宁地区医院作为国家肠道筛查计划一部分转诊而来的患者,并将其分为两组之一:Endocuff Vision结肠镜检查(EVC)组和标准结肠镜检查(SC)组。观察指标为每次检查的ADR、病变的平均数量、部位和大小。在纳入研究开始后,增加SLDR作为观察指标。
共纳入1178名参与者,其中1166名(EVC组583名,SC组583名)可进行分析。两组间ADR(59.2%[CI 55.1;63.1]对60.5%[CI 56.5;64.4])或SLDR(13.0%[CI 10.5;16.0]对10.3%[CI 8.0;13.0])无临床相关差异。每次检查发现的锯齿状病变更多(MSP)(0.2对0.1,IRR 57%[CI 17;109])。两个研究组中EV的切除率相似。
与标准结肠镜检查相比,我们发现使用Endocuff Vision对ADR无显著影响,但Endocuff组发现的锯齿状病变更多。
临床试验NCT04651062。