A NOVEL COMPUTER-AIDED POLYP DETECTION SYSTEM IN DAILY CLINICAL CARE: AN INTERNATIONAL MULTICENTER, RANDOMIZED, TANDEM TRIAL

Introduction: Although colonoscopy is considered the gold standard for detection and removal of premalignant polyps, up to 26% of lesions are missed in tandem studies. Computer-aided polyp detection (CADe) has shown promise in increasing polyp detection rates. The aim of this study was to evaluate a novel CADe system, ‘Magentiq Eye Automatic Polyp Detection System’ (ME-APDS), in a non-iFOBT screening and surveillance colonoscopy population.

Methods: A multicenter, randomized, controlled (RCT) trial was conducted at 10 hospitals in Europe, US and Israel. Patients (18-90 years), referred for screening (non-iFOBT) or surveillance colonoscopy, were included. Patients were randomized (1:1) to undergo CADe-assisted colonoscopy or conventional colonoscopy (CC). In each arm, a subset of patients was further randomized to undergo tandem colonoscopy; CADe followed by CC or CC followed by CADe. Primary objective was adenoma per colonoscopy (APC). Secondary objectives were adenoma detection rate (ADR) and adenoma miss rate (AMR). Outcomes were also evaluated by colonoscopy indication (screening and surveillance), adenoma location, and adenoma size.

Results: In total, 950 patients were enrolled, of which 916 completed the assigned colonoscopy, 449 in the CADe-assisted group and 467 in the CC group. APC was higher in CADe-arm compared to CC (0.70 vs. 0.51, p=0.015; total adenomas, 314 vs. 238). Overall, ADR was higher in CADe compared to CC (37% vs. 30%, p=0.014). Apart from diminutive (0-5mm) adenomas, use of CADe also increased the detection of small (6-9mm) adenomas compared to CC (14.3% vs. 9.9%, p=0.036). Moreover, an increase in proximal adenoma detection was observed in CADe-assisted colonoscopy compared to CC (46.6% vs. 31.1%, p=0.006). A total of 127 (61 CADe first, 64 CC first) patients completed tandem colonoscopy. AMR was 19% in CADe first compared to 36% in CC first (p=0.024). Use of ME-CADe had no impact on withdrawal times (p=0.861).

Conclusion: ME-APDS increased adenoma detection (both APC and ADR) in non-iFOBT screening and surveillance colonoscopies, and reduced AMR by two-fold compared to CC. Apart from diminutive lesions, ME-APDS increased the detection of 6-9mm adenomas suggesting that this novel CADe system is also able to detect more clinically relevant lesions.