Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Medicine I, Division of Gastroenterology, Universitätsklinikum Erlangen, Erlangen, Germany.
Endoscopy. 2024 Nov;56(11):843-850. doi: 10.1055/a-2328-2844. Epub 2024 May 15.
Computer-aided detection (CADe) has been developed to improve detection during colonoscopy. After initial reports of high efficacy, there has been an increasing recognition of variability in the effectiveness of CADe systems. The aim of this study was to evaluate a CADe system in a varied colonoscopy population.
A multicenter, randomized trial was conducted at seven hospitals (both university and non-university) in Europe and Canada. Participants referred for diagnostic, non-immunochemical fecal occult blood test (iFOBT) screening, or surveillance colonoscopy were randomized (1:1) to undergo CADe-assisted or conventional colonoscopy by experienced endoscopists. Participants with insufficient bowel preparation were excluded from the analysis. The primary outcome was adenoma detection rate (ADR). Secondary outcomes included adenomas per colonoscopy (APC) and sessile serrated lesions (SSLs) per colonoscopy.
581 participants were enrolled, of whom 497 were included in the final analysis: 250 in the CADe arm and 247 in the conventional colonoscopy arm. The indication was surveillance in 202/497 colonoscopies (40.6 %), diagnostic in 199/497 (40.0 %), and non-iFOBT screening in 96/497 (19.3 %). Overall, ADR (38.4 % vs. 37.7 %; = 0.43) and APC (0.66 vs. 0.66; = 0.97) were similar between CADe and conventional colonoscopy. SSLs per colonoscopy was increased (0.30 vs. 0.19; = 0.049) in the CADe arm vs. the conventional colonoscopy arm.
In this study conducted by experienced endoscopists, CADe did not result in a statistically significant increase in ADR. However, the ADR of our control group substantially surpassed our sample size assumptions, increasing the risk of an underpowered trial.
计算机辅助检测（CADe）的发展旨在提高结肠镜检查中的检测能力。在最初报告显示其具有高疗效后，人们越来越认识到 CADe 系统的有效性存在差异。本研究旨在评估一种在不同结肠镜检查人群中的 CADe 系统。
在欧洲和加拿大的七家医院（包括大学和非大学医院）进行了一项多中心、随机试验。参与者被随机（1:1）分配到接受 CADe 辅助或传统结肠镜检查，这些参与者是因诊断、非免疫化学粪便潜血试验（iFOBT）筛查或监测性结肠镜检查而被转介。因肠道准备不足而被排除在分析之外的参与者也包括在内。主要结局是腺瘤检出率（ADR）。次要结局包括每例结肠镜检查的腺瘤数（APC）和每例结肠镜检查的无蒂锯齿状病变（SSL）数。
共纳入 581 名参与者，其中 497 名参与者纳入最终分析：250 名在 CADe 组，247 名在传统结肠镜检查组。结肠镜检查的适应证分别为监测 202/497 例（40.6%）、诊断 199/497 例（40.0%）和非 iFOBT 筛查 96/497 例（19.3%）。总体而言，CADe 与传统结肠镜检查的 ADR（38.4%比 37.7%； = 0.43）和 APC（0.66 比 0.66； = 0.97）相似。与传统结肠镜检查组相比，CADe 组每例结肠镜检查的 SSLs 数量增加（0.30 比 0.19； = 0.049）。
在这项由经验丰富的内镜医生进行的研究中，CADe 并未导致 ADR 出现统计学上的显著增加。然而，我们对照组的 ADR 大大超过了我们的样本量假设，增加了试验效力不足的风险。
