Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial
Standard
Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. / 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.
In: GASTROENTEROLOGY, Vol. 159, No. 2, 08.2020, p. 512-520.e7.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial
AU - Repici, Alessandro
AU - Badalamenti, Matteo
AU - Maselli, Roberta
AU - Correale, Loredana
AU - Radaelli, Franco
AU - Rondonotti, Emanuele
AU - Ferrara, Elisa
AU - Spadaccini, Marco
AU - Alkandari, Asma
AU - Fugazza, Alessandro
AU - Anderloni, Andrea
AU - Galtieri, Piera Alessia
AU - Pellegatta, Gaia
AU - Carrara, Silvia
AU - Di Leo, Milena
AU - Craviotto, Vincenzo
AU - Lamonaca, Laura
AU - Lorenzetti, Roberto
AU - Andrealli, Alida
AU - Antonelli, Giulio
AU - Wallace, Michael
AU - Sharma, Prateek
AU - Rosch, Thomas
AU - Hassan, Cesare
N1 - Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.
PY - 2020/8
Y1 - 2020/8
N2 - BACKGROUND & AIMS: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.
AB - BACKGROUND & AIMS: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.
U2 - 10.1053/j.gastro.2020.04.062
DO - 10.1053/j.gastro.2020.04.062
M3 - SCORING: Journal article
C2 - 32371116
VL - 159
SP - 512-520.e7
JO - GASTROENTEROLOGY
JF - GASTROENTEROLOGY
SN - 0016-5085
IS - 2
ER -