Efficacy of a computer-aided detection system in a fecal immunochemical test-based organized colorectal cancer screening program: a randomized controlled trial (AIFIT study).


Journal

Endoscopy
ISSN: 1438-8812
Titre abrégé: Endoscopy
Pays: Germany
ID NLM: 0215166

Informations de publication

Date de publication:
12 2022
Historique:
pubmed: 12 5 2022
medline: 2 12 2022
entrez: 11 5 2022
Statut: ppublish

Résumé

Computer-aided detection (CADe) increases adenoma detection in primary screening colonoscopy. The potential benefit of CADe in a fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening program is unknown. This study assessed whether use of CADe increases the adenoma detection rate (ADR) in a FIT-based CRC screening program. In a multicenter, randomized trial, FIT-positive individuals aged 50-74 years undergoing colonoscopy, were randomized (1:1) to receive high definition white-light (HDWL) colonoscopy, with or without a real-time deep-learning CADe by endoscopists with baseline ADR > 25 %. The primary outcome was ADR. Secondary outcomes were mean number of adenomas per colonoscopy (APC) and advanced adenoma detection rate (advanced-ADR). Subgroup analysis according to baseline endoscopists' ADR (≤ 40 %, 41 %-45 %, ≥ 46 %) was also performed. 800 individuals (median age 61.0 years [interquartile range 55-67]; 409 men) were included: 405 underwent CADe-assisted colonoscopy and 395 underwent HDWL colonoscopy alone. ADR and APC were significantly higher in the CADe group than in the HDWL arm: ADR 53.6 % (95 %CI 48.6 %-58.5 %) vs. 45.3 % (95 %CI 40.3 %-50.45 %; RR 1.18; 95 %CI 1.03-1.36); APC 1.13 (SD 1.54) vs. 0.90 (SD 1.32; Incorporating CADe significantly increased ADR and APC in the framework of a FIT-based CRC screening program. The impact of CADe appeared to be consistent regardless of endoscopist baseline ADR.

Sections du résumé

BACKGROUND
Computer-aided detection (CADe) increases adenoma detection in primary screening colonoscopy. The potential benefit of CADe in a fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening program is unknown. This study assessed whether use of CADe increases the adenoma detection rate (ADR) in a FIT-based CRC screening program.
METHODS
In a multicenter, randomized trial, FIT-positive individuals aged 50-74 years undergoing colonoscopy, were randomized (1:1) to receive high definition white-light (HDWL) colonoscopy, with or without a real-time deep-learning CADe by endoscopists with baseline ADR > 25 %. The primary outcome was ADR. Secondary outcomes were mean number of adenomas per colonoscopy (APC) and advanced adenoma detection rate (advanced-ADR). Subgroup analysis according to baseline endoscopists' ADR (≤ 40 %, 41 %-45 %, ≥ 46 %) was also performed.
RESULTS
800 individuals (median age 61.0 years [interquartile range 55-67]; 409 men) were included: 405 underwent CADe-assisted colonoscopy and 395 underwent HDWL colonoscopy alone. ADR and APC were significantly higher in the CADe group than in the HDWL arm: ADR 53.6 % (95 %CI 48.6 %-58.5 %) vs. 45.3 % (95 %CI 40.3 %-50.45 %; RR 1.18; 95 %CI 1.03-1.36); APC 1.13 (SD 1.54) vs. 0.90 (SD 1.32;
CONCLUSIONS
Incorporating CADe significantly increased ADR and APC in the framework of a FIT-based CRC screening program. The impact of CADe appeared to be consistent regardless of endoscopist baseline ADR.

Identifiants

pubmed: 35545122
doi: 10.1055/a-1849-6878
doi:

Types de publication

Randomized Controlled Trial Multicenter Study Clinical Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1171-1179

Commentaires et corrections

Type : CommentIn

Informations de copyright

Thieme. All rights reserved.

Déclaration de conflit d'intérêts

E. Rondonotti has received speaker honoraria from Fujifilm Co., is a member of Fujifilm Co. expert group, and is a consultant for Medtronic Co. S. Paggi and A. Amato have received speaker honoraria from Fujifilm Co. F. Radaelli has received speaker honoraria and a research grant (not related to the present study) from Fujifilm Co. C. Hassan C has received equipment on loan from Fujifilm Co. A. Repici is a consultant for and has received research grants (not related to the present study) from Fujifilm Co., Medtronic plc, and Boston Scientific Co; he is also a consultant for Cosmo Pharmaceuticals S.p.A. and Erbe Elektromedizin GmbH. The remaining authors declare that they have no conflict of interest.

Auteurs

Emanuele Rondonotti (E)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Dhanai Di Paolo (D)

Gastroenterology Unit, Valduce Hospital, Como, Italy.
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Department of Gastroenterology and Hepatology, Milan, Italy.

Erik Rosa Rizzotto (ER)

Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy.

Costanza Alvisi (C)

USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy.

Elisabetta Buscarini (E)

Gastroenterology Unit, Azienda Ospedaliera "Ospedale Maggiore", Crema, Italy.

Marco Spadaccini (M)

Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy.
Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy.

Giacomo Tamanini (G)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Silvia Paggi (S)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Arnaldo Amato (A)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Giulia Scardino (G)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Samanta Romeo (S)

Gastroenterology Unit, Azienda Ospedaliera "Ospedale Maggiore", Crema, Italy.

Saverio Alicante (S)

Gastroenterology Unit, Azienda Ospedaliera "Ospedale Maggiore", Crema, Italy.

Fabio Ancona (F)

Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy.

Ennio Guido (E)

Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy.

Vincenza Marzo (V)

USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy.

Fabio Chicco (F)

USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy.

Simona Agazzi (S)

USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy.

Cesare Rosa (C)

USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy.

Loredana Correale (L)

Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy.

Alessandro Repici (A)

Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy.
Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy.

Cesare Hassan (C)

Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy.
Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy.

Franco Radaelli (F)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

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