USE OF A NOVEL ARTIFICIAL INTELLIGENCE SYSTEM LEADS TO THE DETECTION OF SIGNIFICANTLY HIGHER NUMBER OF ADENOMAS DURING SCREENING AND SURVEILLANCE COLONOSCOPY: RESULTS FROM A LARGE, PROSPECTIVE, U.S. MULTI-CENTER, RANDOMIZED CLINICAL TRIAL

Introduction: Adenoma per colonoscopy (APC) has recently been proposed as a quality measure for colonoscopy. We evaluated the impact of a novel AI system, compared to standard HD colonoscopy, for APC measurement.
Methods: This was a U.S. based, multi-center, prospective randomized trial (NCT04979962) investigating a novel AI detection system - EW10-EC02 that enables a real-time colorectal polyp detection enabled with the colonoscope (CAD-EYE™); Figure 1. Eligible average risk subjects (45 and older) undergoing screening or surveillance colonoscopy were randomized to undergo either computer-assisted colonoscopy (CAC) or conventional colonoscopy (CC). Primary outcomes were APC and positive predictive value (PPV, total number of adenomas divided by total polyps removed). Secondary outcomes were withdrawal time, ADR, sessile serrated lesion detection rate, polyp detection rate and polyp per colonoscopy.
Results: Of 1033 subjects (age: 59.1+/-9.8; 49.9% male) randomized, 510 underwent CAC vs. 523 underwent CC with no significant differences in age, gender, ethnicity, or colonoscopy indication between the 2 groups. For the primary aim, CAC led to a significantly higher APC compared to CC: 0.99± 1.6 vs. 0.85±1.5, p=0.02, Incident Rate Ratio 1.17 (1.03-1.33, p=0.02) with no significant difference in the withdrawal time: 11.28±4.59 min vs. 10.8±4.81 min; p=0.11 between the 2 groups. For the co-primary end point, the positive predictive value of a polyp being adenoma (or non-adenoma) was not inferior (<10%). There were no significant differences in ADR (46.9% vs. 42.8%), advanced adenoma (6.5% vs. 6.3%), sessile serrated lesion detection rate (12.9% vs. 10.1%) and polyp detection rate (63.9% vs 59.3%) between the 2 groups. There was a higher polyp per colonoscopy with CAC compared to CC: 1.67 ± 2.1 vs. 1.33 ± 1.8 (incidence rate ratio 1.27; 1.15-1.4; p<0.01).
Conclusion: Use of a novel AI detection system leads to a significantly higher number of adenomas per colonoscopy compared to conventional HD colonoscopy without any increase in colonoscopy withdrawal time, thus supporting use of AI-assisted colonoscopy to improve colonoscopy quality.

Figure 1. (a and b) Polyp is detected by the CADEYE system with rectangular blue box