Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 159; no. 2; pp. 512 - 520.e7
• Main Authors: Repici, Alessandro, Badalamenti, Matteo, Maselli, Roberta, Correale, Loredana, Radaelli, Franco, Rondonotti, Emanuele, Ferrara, Elisa, Spadaccini, Marco, Alkandari, Asma, Fugazza, Alessandro, Anderloni, Andrea, Galtieri, Piera Alessia, Pellegatta, Gaia, Carrara, Silvia, Di Leo, Milena, Craviotto, Vincenzo, Lamonaca, Laura, Lorenzetti, Roberto, Andrealli, Alida, Antonelli, Giulio, Wallace, Michael, Sharma, Prateek, Rosch, Thomas, Hassan, Cesare
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2020
• Subjects: Adenoma - diagnosis; Adenoma - epidemiology; Adenoma - pathology; Adenoma Per Colonoscopy; Aged; Artificial Intelligence; Biopsy - statistics & numerical data; Colon - diagnostic imaging; Colon - pathology; Colonoscopy - instrumentation; Colonoscopy - methods; Colonoscopy - statistics & numerical data; Colorectal Neoplasms - diagnosis; Colorectal Neoplasms - epidemiology; Colorectal Neoplasms - pathology; Comparison; Deep Learning; Early Detection; Female; Humans; Image Interpretation, Computer-Assisted - instrumentation; Image Interpretation, Computer-Assisted - methods; Image Interpretation, Computer-Assisted - statistics & numerical data; Male; Mass Screening - instrumentation; Mass Screening - methods; Mass Screening - statistics & numerical data; Middle Aged; Time Factors; Adenoma Per Colonoscopy; Early Detection; FIT; CADe; RR; APC; Comparison; CRC; Artificial Intelligence; CI; SSL; ADR
• ISSN: 0016-5085; 1528-0012; 1528-0012
• DOI: 10.1053/j.gastro.2020.04.062

One-fourth of colorectal neoplasias are missed during screening colonoscopies; these can develop into colorectal cancer (CRC). Deep learning systems allow for real-time computer-aided detection (CADe) of polyps with high accuracy. We performed a multicenter, randomized trial to assess the safety and efficacy of a CADe system in detection of colorectal neoplasias during real-time colonoscopy. We analyzed data from 685 subjects (61.32 ± 10.2 years old; 337 men) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or workup due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at 3 centers in Italy from September through November 2019. Patients were randomly assigned (1:1) to groups who underwent high-definition colonoscopies with the CADe system or without (controls). The CADe system included an artificial intelligence–based medical device (GI-Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display a green box over suspected lesions. A minimum withdrawal time of 6 minutes was required. Lesions were collected and histopathology findings were used as the reference standard. The primary outcome was adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, non-neoplastic resection rate, and withdrawal time. The ADR was significantly higher in the CADe group (54.8%) than in the control group (40.4%) (relative risk [RR], 1.30; 95% confidence interval [CI], 1.14–1.45). Adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07 ±1.54) than in the control group (mean 0.71 ± 1.20) (incidence rate ratio, 1.46; 95% CI, 1.15–1.86). Adenomas 5 mm or smaller were detected in a significantly higher proportion of subjects in the CADe group (33.7%) than in the control group (26.5%; RR, 1.26; 95% CI, 1.01–1.52), as were adenomas of 6 to 9 mm (detected in 10.6% of subjects in the CADe group vs 5.8% in the control group; RR, 1.78; 95% CI, 1.09–2.86), regardless of morphology or location. There was no significant difference between groups in withdrawal time (417 ± 101 seconds for the CADe group vs 435 ± 149 for controls; P = .1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90–1.12). In a multicenter, randomized trial, we found that including CADe in real-time colonoscopy significantly increases ADR and adenomas detected per colonoscopy without increasing withdrawal time. ClinicalTrials.gov no: 04079478 [Display omitted]