Original Research
29 August 2023

Role of Artificial Intelligence in Colonoscopy Detection of Advanced Neoplasias: A Randomized Trial

Publication: Annals of Internal Medicine
Volume 176, Number 9
Visual Abstract. Role of Artificial Intelligence in Colonoscopy Detection of Advanced Neoplasias
Artificial intelligence (AI)–assisted colonoscopy aims to augment colorectal polyp detection by human endoscopists, but its impact on detecting high-risk or advanced colorectal neoplasia remains uncertain. The primary objective of this trial was to investigate whether AI-assisted colonoscopy enables endoscopists to identify more patients with advanced colorectal polyps than conventional colonoscopy.

Abstract

Background:

The role of computer-aided detection in identifying advanced colorectal neoplasia is unknown.

Objective:

To evaluate the contribution of computer-aided detection to colonoscopic detection of advanced colorectal neoplasias as well as adenomas, serrated polyps, and nonpolypoid and right-sided lesions.

Design:

Multicenter, parallel, randomized controlled trial. (ClinicalTrials.gov: NCT04673136)

Setting:

Spanish colorectal cancer screening program.

Participants:

3213 persons with a positive fecal immunochemical test.

Intervention:

Enrollees were randomly assigned to colonoscopy with or without computer-aided detection.

Measurements:

Advanced colorectal neoplasia was defined as advanced adenoma and/or advanced serrated polyp.

Results:

The 2 comparison groups showed no significant difference in advanced colorectal neoplasia detection rate (34.8% with intervention vs. 34.6% for controls; adjusted risk ratio [aRR], 1.01 [95% CI, 0.92 to 1.10]) or the mean number of advanced colorectal neoplasias detected per colonoscopy (0.54 [SD, 0.95] with intervention vs. 0.52 [SD, 0.95] for controls; adjusted rate ratio, 1.04 [99.9% CI, 0.88 to 1.22]). Adenoma detection rate also did not differ (64.2% with intervention vs. 62.0% for controls; aRR, 1.06 [99.9% CI, 0.91 to 1.23]). Computer-aided detection increased the mean number of nonpolypoid lesions (0.56 [SD, 1.25] vs. 0.47 [SD, 1.18] for controls; adjusted rate ratio, 1.19 [99.9% CI, 1.01 to 1.41]), proximal adenomas (0.94 [SD, 1.62] vs. 0.81 [SD, 1.52] for controls; adjusted rate ratio, 1.17 [99.9% CI, 1.03 to 1.33]), and lesions of 5 mm or smaller (polyps in general and adenomas and serrated lesions in particular) detected per colonoscopy.

Limitations:

The high adenoma detection rate in the control group may limit the generalizability of the findings to endoscopists with low detection rates.

Conclusion:

Computer-aided detection did not improve colonoscopic identification of advanced colorectal neoplasias.

Primary Funding Source:

Medtronic.

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Supplemental Material

Supplement.

Supplement Study Protocol.

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Information & Authors

Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 176Number 9September 2023
Pages: 1145 - 1152

History

Published online: 29 August 2023
Published in issue: September 2023

Keywords

Authors

Affiliations

Carolina Mangas-Sanjuan, MD, PhD https://orcid.org/0000-0003-2611-1051
Department of Gastroenterology, Hospital General Universitario Dr. Balmis, Servicio de Medicina Digestiva, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Spain (C.M., N.S.)
Luisa de-Castro, MD, PhD https://orcid.org/0000-0001-7848-7910
Department of Gastroenterology, Hospital Álvaro Cunqueiro, Digestive Pathology Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain (L. de-C., N.F.)
Joaquín Cubiella, MD, PhD https://orcid.org/0000-0002-9994-4831
Department of Gastroenterology, Hospital Universitario de Ourense, Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense, Spain (J.C., S.Z.)
Pilar Díez-Redondo, MD, PhD https://orcid.org/0000-0002-8364-6741
Department of Gastroenterology, Hospital Río-Hortega, Valladolid, Spain (P.D., H.N.)
Department of Gastroenterology, Hospital Central de Asturias, Oviedo, Spain (A.S., V.A.)
María Pellisé, MD, PhD https://orcid.org/0000-0001-9739-4998
Department of Gastroenterology, Hospital Clínic Barcelona, Barcelona, Spain (M.P., O.O.)
Nereida Fernández, MD
Department of Gastroenterology, Hospital Álvaro Cunqueiro, Digestive Pathology Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain (L. de-C., N.F.)
Department of Gastroenterology, Hospital Universitario de Ourense, Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense, Spain (J.C., S.Z.)
Henar Núñez-Rodríguez, MD, PhD https://orcid.org/0000-0002-3676-3144
Department of Gastroenterology, Hospital Río-Hortega, Valladolid, Spain (P.D., H.N.)
Verónica Álvarez-García, MD, PhD https://orcid.org/0000-0002-3972-8643
Department of Gastroenterology, Hospital Central de Asturias, Oviedo, Spain (A.S., V.A.)
Department of Gastroenterology, Hospital Clínic Barcelona, Barcelona, Spain (M.P., O.O.)
Department of Gastroenterology, Hospital General Universitario Dr. Balmis, Servicio de Medicina Digestiva, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Spain (C.M., N.S.)
Hospital General Universitario Dr. Balmis, Clinical Pharmacology Department, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Departamento de Farmacología, Universidad Miguel Hernández, Alicante, CIBERehd, Spain (P.Z.)
Department of Gastroenterology, Hospital General Universitario Dr. Balmis, Servicio de Medicina Digestiva, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Departamento de Medicina Clínica, Universidad Miguel Hernández, Alicante, Spain (R.J.).
CADILLAC study investigators
Financial Support: Supported by a research grant from Medtronic (CPRESA00135). This work was supported also by the Instituto de Salud Carlos III (PI20/01527). The Asociación para la Investigación en Gastroenterología de la Provincia de Alicante (AIGPA), a private association that promotes research in gastrointestinal diseases in Alicante, also supported the logistical aspects of the study, but declares no conflict of interest.
Disclosures: All relevant financial relationships have been mitigated. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-2619.
Data Sharing Statement: The authors have indicated they will not be sharing data.
Corresponding Author: Rodrigo Jover, MD, PhD, Servicio de Medicina Digestiva, Hospital General Universitario Dr. Balmis, C/Pintor Baeza 12, 03010 Alicante, Spain; e-mail, [email protected].
Author Contributions: Conception and design: R. Jover, C. Mangas-Sanjuan
Analysis and interpretation of the data: R. Jover, C. Mangas-Sanjuan, P. Zapater
Drafting of the article: V. Álvarez-García, J. Cubiella, L. de-Castro, P. Díez-Redondo, N. Fernández, R. Jover, C. Mangas-Sanjuan, H. Núñez-Rodríguez, O. Ortiz, M. Pellisé, N. Sala-Miquel, A. Suárez, P. Zapater, S. Zarraquiños
Critical revision for important intellectual content: J. Cubiella, L. de-Castro, P. Díez-Redondo, R. Jover, C. Mangas-Sanjuan, M. Pellisé, A. Suárez
Final approval of the article: V. Álvarez-García, J. Cubiella, L. de-Castro, P. Díez-Redondo, N. Fernández, R. Jover, C. Mangas-Sanjuan, H. Núñez-Rodríguez, O. Ortiz, M. Pellisé, N. Sala-Miquel, A. Suárez, P. Zapater, S. Zarraquiños
Provision of study materials or patients: V. Álvarez-García, J. Cubiella, L. de-Castro, P. Díez-Redondo, N. Fernández, R. Jover, C. Mangas-Sanjuan, H. Núñez-Rodríguez, O. Ortiz, M. Pellisé, N. Sala-Miquel, A. Suárez, P. Zapater, S. Zarraquiños
Statistical expertise: P. Zapater
Obtaining of funding: R. Jover
Administrative, technical, or logistic support: R. Jover, C. Mangas-Sanjuan
Collection and assembly of data: V. Álvarez-García, J. Cubiella, L. de-Castro, P. Díez-Redondo, N. Fernández, R. Jover, C. Mangas-Sanjuan, H. Núñez-Rodríguez, O. Ortiz, M. Pellisé, N. Sala-Miquel, A. Suárez, P. Zapater, S. Zarraquiños
This article was published at Annals.org on 29 August 2023.
* For a list of the CADILLAC study investigators, see the Appendix.

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Carolina Mangas-Sanjuan, Luisa de-Castro, Joaquín Cubiella, et al; CADILLAC study investigators. Role of Artificial Intelligence in Colonoscopy Detection of Advanced Neoplasias: A Randomized Trial. Ann Intern Med.2023;176:1145-1152. [Epub 29 August 2023]. doi:10.7326/M22-2619

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