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; Dhanai Di Paolo; Erik Rosa Rizzotto; Costanza Alvisi; Elisabetta Buscarini; Marco Spadaccini; Giacomo Tamanini; Silvia Paggi; Arnaldo Amato; Giulia Scardino; Samanta Romeo; Saverio Alicante; Fabio Ancona; Ennio Guido; Vincenza Marzo; Fabio Chicco; Simona Agazzi; Cesare Rosa; Loredana Correale; Alessandro Repici; Cesare Hassan; Franco Radaelli; on behalf of the AIFIT Study Group

doi:10.1055/a-1849-6878

Endoscopy, Table of Contents

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

¹Gastroenterology Unit, Valduce Hospital, Como, Italy

,

Dhanai Di Paolo

¹Gastroenterology Unit, Valduce Hospital, Como, Italy

²Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Department of Gastroenterology and Hepatology, Milan, Italy

,

Erik Rosa Rizzotto

³Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy

,

Costanza Alvisi

⁴USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy

,

Elisabetta Buscarini

⁵Gastroenterology Unit, Azienda Ospedaliera “Ospedale Maggiore”, Crema, Italy

,

Marco Spadaccini

⁶Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy

⁷Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy

,

Giacomo Tamanini

¹Gastroenterology Unit, Valduce Hospital, Como, Italy

,

Silvia Paggi

¹Gastroenterology Unit, Valduce Hospital, Como, Italy

,

Arnaldo Amato

¹Gastroenterology Unit, Valduce Hospital, Como, Italy

,

Giulia Scardino

¹Gastroenterology Unit, Valduce Hospital, Como, Italy

,

Samanta Romeo

⁵Gastroenterology Unit, Azienda Ospedaliera “Ospedale Maggiore”, Crema, Italy

,

Saverio Alicante

⁵Gastroenterology Unit, Azienda Ospedaliera “Ospedale Maggiore”, Crema, Italy

,

Fabio Ancona

³Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy

,

Ennio Guido

³Gastroenterology Unit, St. Antonio Hospital, Azienda Ospedaliera Universitaria, Padova, Italy

,

Vincenza Marzo

⁴USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy

,

Fabio Chicco

⁴USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy

,

Simona Agazzi

⁴USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy

,

Cesare Rosa

⁴USD Endoscopia Digestiva, ASST Pavia, Pavia, Italy

,

Loredana Correale

⁶Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy

,

Alessandro Repici

⁶Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy

⁷Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy

,

Cesare Hassan

⁶Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy

⁷Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy

,

Franco Radaelli

¹Gastroenterology Unit, Valduce Hospital, Como, Italy

,

on behalf of the AIFIT Study Group

› Author Affiliations

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.

Full Text

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Supplementary Material

Supplementary material