Introduction
Computer-aided detection (CADe) systems have gained attention for their use in colonoscopy, with growing evidence of increased adenoma detection rates (ADR). However, results remain inconsistent, and debate regarding their usefulness continues, including their impact on serrated lesion (SL) detection and performance across varying levels of endoscopist expertise. Given that CADe is used as a real-time assistive tool, it is crucial to confirm its efficacy in lesion detection before considering long-term outcomes.
Aims & Methods
We conducted a multinational, multicenter randomized controlled trial in the Asia-Pacific (Project CAD/NCCH2217; jRCT1032230396) to assess the efficacy of CADe in improving lesion detection during colonoscopy performed as part of colorectal cancer (CRC) screening [1]. We enrolled asymptomatic individuals aged 50–79 years undergoing either primary screening colonoscopy or colonoscopy following a positive fecal immunochemical test (FIT), who had not received colonoscopy in the past 5 years. Participants were randomly assigned (1:1) to the CADe group (colonoscopy with CADe assistance) or the standard group (colonoscopy without CADe) using a minimization method to balance age, sex, colonoscopy indication, endoscopist experience, and country/region. In the CADe group, approved CADe devices were used in accordance with each country's regulations, including EndoBRAIN-EYE, ENDO-AID, CAD EYE, and WISE VISION. All procedures were performed by endoscopists with experience of ≥500 colonoscopies. The primary endpoint was adenoma detection rate (ADR). Secondary endpoints included adenomas per colonoscopy (APC), advanced ADR (AADR), sessile serrated lesion detection rate (SSLDR), sessile serrated lesions per colonoscopy (SSLPC), scope withdrawal time, and the resection rate of non-neoplastic lesions. Planned sample size was 1400 cases (one-sided α = 0.05, 80% power).
Results
Of the 1,399 participants enrolled between December 28, 2023, and March 6, 2025, 1,373 were included in the full analysis set (688 and 685 in the CADe and standard groups, respectively). In both groups, the proportions of primary screening and post-FIT colonoscopies were 75% and 25%, respectively. No differences were observed between the CADe and standard groups in ADR (54.7% vs. 53.9%; odds ratio [OR] 1.04; 95% confidence interval [CI], 0.83–1.30, one-sided p=0.38), APC (1.17 vs. 1.24; risk ratio [RR], 0.94; 95% CI, 0.81–1.09), or AADR (5.5% vs. 7.6%; OR, 0.71; 95% CI, 0.46–1.10). The CADe group showed higher SSLDR (9.0% vs. 6.0%; OR, 1.55; 95% CI, 1.03–2.33) and SSLPC (0.11 vs. 0.07; RR, 1.65; 95% CI, 1.09–2.50). Subgroup analysis based on endoscopist experience demonstrated a higher SSLDR in the CADe group among those with 500–4,999 (10.1% vs. 5.4%) and 5,000–9,999 (11.9% vs. 3.6%) prior colonoscopies, but not among those with experience of ≥10,000 procedures (7.0% vs. 7.5%). There was no difference between groups in the non-neoplastic lesion resection rate (14.7% vs. 13.4%; OR, 1.11; 95% CI, 0.82–1.50), and the median scope withdrawal time in cases without polypectomy was 9 minutes in both groups.
Conclusion
CADe assistance did not improve adenoma detection where high ADR was already achieved with standard colonoscopy. Nevertheless, it enhanced SSL detection, except among highly experienced endoscopists, without prolonging withdrawal time or increasing unnecessary polypectomies. While our findings do not overstate the efficacy of CADe, they support a reasonable and practical role for its use in improving colonoscopy quality in CRC screening.
References
1. Sekiguchi M, et al. Protocol for a multicenter randomized controlled trial to assess the usefulness of computer-aided detection systems for colonoscopy in colorectal cancer screening in the Asia-Pacific region (project CAD/NCCH2217). Jpn J Clin Oncol. 2025; 55: 837-40.
Disclosure
The authors have no conflict of interest related with this study.