Introduction
Several Randomized Controlled Trials (RCTs) have evaluated the role of artificial intelligence (AI) Computer-Aided Detection (CADe) systems to enhance polyp detection. However, these studies have focused exclusively on locally deployed hardware-based AI systems, whereas cloud-based systems may improve the accessibility and upgrading of CADe technology. ‘CADDIE’ (Odin Vision, an Olympus company) is a cloud-based CADe system that receives the live endoscopy image stream via the hospital’s internet network, where the AI algorithm processes the images, and overlays real-time bounding boxes on the endoscopy screen to highlight suspected polyps.
Aims & Methods
This prospective RCT aimed to evaluate the efficacy and safety of the novel cloud-based CADe-system in improving polyp detection.
This international, multi-centre, parallel-group RCT was conducted across eight centres in four European countries. Participating endoscopists had a baseline of >1000 colonoscopy procedures and an adenoma detection rate (ADR) of ≥25%. Patients aged ≥40 years and at average risk for colorectal cancer undergoing screening or surveillance indications for colonoscopy were recruited. Patients were randomised in a 1:1 ratio to standard colonoscopy (SoC) or CADDIE-assisted (CADe-arm) colonoscopy. The co-primary endpoints were superiority in adenomas per colonoscopy (APC) as the efficacy endpoint, and non-inferiority for the Positive Percent Agreement (PPA), defined as the percentage of resections that are histologically confirmed adenomas, SSLs and large (>10mm) hyperplastic polyps of the proximal colon, as the safety endpoint.
Results
Overall, 22 endoscopists and 841 participants were included in the analysis. The CADe-arm significantly increased APC by 33% (0.62 vs 0.82, Ratio 1.33 [95%CI 1.06-1.67], p=0.01) and ADR (35.9% vs 43.2%, difference of 7.3% [95%CI 0.7%-13.9%], p=0.03) compared to the SoC-arm. The mean detection of sessile serrated lesions (SSLs) (0.03 vs 0.08, Ratio 3.30 [95%CI 1.41-7.57], p<0.01), large adenomas (0.04 vs 0.09; Ratio 1.93 [95%CI 1.03-3.62], p=0.04), and large polyps (0.05 vs 0.12; Ratio 2.36 [95%CI 1.33-4.17], p<0.01) also significantly improved. A higher proportion of large polyps (27.3% vs. 37.0%) and large adenomas (15.8% vs 24.2%) were non-polypoid ‘flat’ morphology in the CADe-arm compared to the SoC-arm. Other detection metrics, including neoplastic polyps per colonoscopy (0.66 vs 0.91; Ratio 1.39 [95%CI 1.12-1.73], p<0.01) and polyps per colonoscopy (1.06 vs 1.41 (Ratio 1.35 [95%CI 1.13-1.61], p<0.01), also significantly increased.
Non-inferiority in PPA was achieved (53.4% vs 53.9%; 0.5% (-5.0%,∞)), with no increase in unnecessary resections.
Outcome
| Study Arm
| Patients (N)
| Results | Difference (95% CI)
| P-value
|
APC
| SoC
| 424
| 0.62 ± 1.19
| 1
| 0.01
|
CADe
| 417
| 0.82 ± 1.40
| 1.33 (1.06, 1.67)
|
ADR
| SoC
| 424
| 35.9%
| 0 | 0.03
|
CADe
| 417
| 43.2%
| 7.3% (0.7%, 13.9%)
|
SSL-PC
| SoC
| 424
| 0.03 ± 0.16
| 1
| <0.01 |
CADe
| 417
| 0.08 ± 0.45
| 3.30 (1.41, 7.57)
|
| PPC | SoC
| 424
| 1.06 ± 1.53
| 1
| <0.01
|
CADe
| 417
| 1.41 ± 1.85
| 1.35 (1.13, 1.61)
|
Table 1: Study results. ADR = Adenoma detection rate, APC = mean Adenomas Per Colonoscopy, PPC = Polyps Per Colonoscopy, SSL-PC = Sessile Serrated Lesions Per Colonoscopy.
Conclusion
This trial demonstrates the safety and efficacy of a cloud-based CADe-system to increase endoscopists' polyp detection across multiple metrics, notably for large adenomas, large polyps, and SSLs.
Disclosure
AR, CS, LBL, RK have received medical consultancy fees from Odin Medical Ltd