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Usefulness of a novel computer-aided detection system for colorectal neoplasia: A randomized controlled trial.

  • Antonio Z. Gimeno-García
    Correspondence
    Corresponding author: AZ Gimeno García, MD; Hospital Universitario de Canarias, Unidad de Endoscopia (10a planta), Ofra s/n.38320, La Laguna, Tenerife, Spain. Telephone/fax: -34-922678554
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Domingo Hernández Negrin
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Anjara Hernández
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • David Nicolás-Pérez
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Eduardo Rodríguez
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Carlota Montesdeoca
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Onofre Alarcon
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Rafael Romero
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • José Luis Baute Dorta
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Yaiza Cedrés
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Rocío del Castillo
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Alejandro Jiménez
    Affiliations
    Unidad de Investigación. Hospital Universitario de Canarias, Tenerife, Spain
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  • Vanessa Felipe
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Dalia Morales
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Juan Ortega
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Cristina Reygosa
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Enrique Quintero
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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  • Manuel Hernández-Guerra
    Affiliations
    Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain
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Published:October 10, 2022DOI:https://doi.org/10.1016/j.gie.2022.09.029
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      Abstract

      Background and study aims

      Artificial intelligence-based computer-aid detection (CADe) devices have been recently tested in colonoscopies, increasing the adenoma detection rate (ADR), mainly in Asian populations. However, there is still low evidence for the benefit of these devices in the occidental population. We tested a new CADe device, namely, ENDO-AID (OIP-1) (Olympus, Japan), in clinical practice.

      Patients and Methods

      This randomized controlled trial included 370 consecutive patients who were randomized 1:1 to CADe (n=185) versus standard exploration (n=185) from November 2021 to January 2022. The primary endpoint was the ADR. Advanced adenoma was defined as ≥ 10mm, harboring high grade dysplasia or with villous pattern. Otherwise, the adenoma was nonadvanced. ADR was assessed in both groups stratified by endoscopist ADR and colon cleansing.

      Results

      In the intention-to-treat analysis the ADR was 55.1% (n=102/185) in the CADe group and 43.8% (n=81/185) in the control group (P=0.029). Nonadvanced ADRs (54.8% vs. 40.8%, P=0.01) and flat ADRs (39.4 vs. 24.8, P=0.006), polyp detection rate (67.1% vs. 51%; P=0.004) and number of adenomas per colonoscopy were significantly higher in the CADe group than in the control group (median [Percentile 25th-75th]: 1 [0-2] vs. 0 [0-1.5], respectively; p= 0.014). No significant differences were found in serrated adenoma detection rate. After stratification by endoscopist and bowel cleansing, no statistically significant differences in ADR were found.

      Conclusion

      Colonoscopy assisted by ENDO-AID (OIP-1) increases ADR and APC, suggesting that it may prevent the overlooking of colorectal neoplastic lesions, especially because of its detection of diminutive and flat adenomas.

      Graphical abstract

      Keywords

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