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Endoscopy 2022; 54(12): 1171-1179
DOI: 10.1055/a-1849-6878
Original article

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

Emanuele Rondonotti 
1   Gastroenterology Unit, Valduce Hospital, Como, Italy
,
Dhanai Di Paolo
1   Gastroenterology Unit, Valduce Hospital, Como, Italy
2   Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Department of Gastroenterology and Hepatology, Milan, Italy
,
Erik Rosa Rizzotto
3   Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy
,
Costanza Alvisi
4   USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy
,
Elisabetta Buscarini
5   Gastroenterology Unit, Azienda Ospedaliera “Ospedale Maggiore”, Crema, Italy
,
Marco Spadaccini
6   Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy
7   Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy
,
Giacomo Tamanini
1   Gastroenterology Unit, Valduce Hospital, Como, Italy
,
Silvia Paggi
1   Gastroenterology Unit, Valduce Hospital, Como, Italy
,
Arnaldo Amato 
1   Gastroenterology Unit, Valduce Hospital, Como, Italy
,
Giulia Scardino
1   Gastroenterology Unit, Valduce Hospital, Como, Italy
,
Samanta Romeo
5   Gastroenterology Unit, Azienda Ospedaliera “Ospedale Maggiore”, Crema, Italy
,
Saverio Alicante
5   Gastroenterology Unit, Azienda Ospedaliera “Ospedale Maggiore”, Crema, Italy
,
Fabio Ancona
3   Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy
,
Ennio Guido
3   Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy
,
Vincenza Marzo
4   USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy
,
Fabio Chicco
4   USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy
,
Simona Agazzi
4   USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy
,
Cesare Rosa
4   USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy
,
Loredana Correale
6   Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy
,
Alessandro Repici
6   Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy
7   Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy
,
Cesare Hassan
6   Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy
7   Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy
,
Franco Radaelli
1   Gastroenterology Unit, Valduce Hospital, Como, Italy
,
on behalf of the AIFIT Study Group › Author AffiliationsTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT04691401 Type of study: Prospective, Multicentre, Randomized, Controlled Trial
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Referred to by:

Author commentary on Emanuele Rondonotti et al.Endoscopy 2022; 54(12): v44-v44
DOI: 10.1055/a-1865-8110

Referred to by:

Will artificial intelligence-assisted colonoscopy work in cancer screening programs?Endoscopy 2022; 54(12): 1180-1181
DOI: 10.1055/a-1890-5043

Abstract

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; P  = 0.03). No significant difference in advanced-ADR was found (18.5 % [95 %CI 14.8 %–22.6 %] vs. 15.9 % [95 %CI 12.5 %–19.9 %], respectively). An increase in ADR was observed in all endoscopist groups regardless of baseline ADR.

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.

Supplementary material



Publication History

Received: 01 February 2022

Accepted after revision: 11 May 2022

Accepted Manuscript online:
11 May 2022

Article published online:
12 July 2022

© 2022. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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