医学
结肠镜检查
腺瘤
随机对照试验
插入时间
多中心试验
袖口
外科
普通外科
放射科
多中心研究
内科学
结直肠癌
癌症
气道
作者
Kelly E. van Keulen,Ioannis S. Papanikolaou,Terrence Mak,Periklis Apostolopoulos,Helmut Neumann,Gabriele Delconte,Manuele Furnari,Yonne Peters,James Lau,Dimitrios Polymeros,Ruud W.M. Schrauwen,Federica Cavalcoli,Eleni Koukoulioti,Konstantinos Triantafyllou,Joseph C. Anderson,Heiko Pohl,DK Rex,Peter D. Siersema
标识
DOI:10.1016/j.gie.2023.11.017
摘要
Background and aims Endocuff VisionTM has been designed to enhance mucosal visualization thereby improving detection of (pre-)malignant colorectal lesions. This multicenter, international, back-to-back, randomized colonoscopy trial compared adenoma detection rate (ADR) and adenoma miss rate (AMR) between Endocuff Vision-assisted colonoscopy (EVC) and conventional colonoscopy (CC). Methods Patients aged 40-75 years referred for non-immunochemical fecal occult blood test-based screening, surveillance, or diagnostic colonoscopy were included at ten hospitals and randomized into four groups: Group 1; 2xCC, Group 2; CC followed by EVC, Group 3; EVC followed CC and Group 4; 2xEVC. Primary outcomes included ADR and AMR. Results A total of 717 patients were randomized of which 661 patients (92.2%) had one and 646 (90.1%) patients had two completed back-to-back colonoscopies. EVC did not significantly improve ADR compared to CC (41.1% [95%-CI;36.1-46.3] versus 35.5% [95%-CI;30.7-40.6], respectively, P=0.125), but EVC did reduced AMR by 11.7% (29.6% [95%-CI;23.6-36.5] versus 17.9% [95%-CI;12.5-23.5], respectively, P=0.049). AMR of 2xCC compared to 2xEVC was also not significantly different (25.9% [95%-CI;19.3-33.9] versus 18.8% [95%-CI;13.9-24.8], respectively, P=0.172). Only 3.7% of the polyps missed during the first procedures had advanced pathologic features. Factors affecting risk of missing adenomas were age (P=0.002), Boston Bowel Preparation Scale (P=0.008) and region where colonoscopy was performed (P<0.001). Conclusions Our trial shows that EVC reduces the risk of missing adenomas but does not lead to a significant improved ADR. Remarkably, 25% of adenomas are still missed during conventional colonoscopies, which is not different from miss rates reported 25 years ago; reassuringly, advanced features were only found in 3.7% of these missed lesions. Trail registration number NCT03418948
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