The EYE Study Enhancing the Diagnostic Yield of Standard Colonoscopy by Artificial Intelligence Aided Endoscopy (EYE)

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    1120
  • sponsor
    Istituto Clinico Humanitas
Updated on 17 May 2022

Summary

Colorectal cancer (CRC) remains one of the leading causes of mortality among neoplastic diseases in the world[1] . Adequate colonoscopy based CRC screening programs have proved to be the key to reduce the risk of mortality, by early diagnosis of existing CRC and detection of pre-cancerous lesions[2-4] . Nevertheless, long-term effectiveness of colonoscopy is influenced by a range of variables that make it far from a perfect tool[5]. The effectiveness of a colonoscopy mainly depends on its quality, which in turn is dependent on the skill and expertise of the endoscopist. In fact, several studies have shown a significant adenoma miss rate of 24%-35%, especially in patients with diminutive adenomas[6,7] . These data are in line with interval cancers incidence (I-CRC), defined as the percentage of cancers diagnosed after a screening program and before the intended surveillance duration, of approximately 3%-5% [8,9].

The development of the artificial intelligence (AI) applications in the medical field has grown in interest in the past decade. Its performance on increasing automatic polyp and adenoma detection has shown promising results in order to achieve an higher ADR[10]. The use of computer aided diagnosis (CAD) for detection of polyps had initially been studied in ex vivo studies but in the last few years, with the advancement in computer aided technology and emergence of deep learning algorithms, use of AI during colonoscopy has been achieved and more studies have been undertaken [10].

Recently Fujifilm (Tokyo, Japan) has developed a new technology known as "CAD-EYE" aiming to support both colonic polyp detection and characterization during colonoscopy. This technology is now available in Europe, being compatible with the latest generation of Fujifilm endoscopes (ELUXEO Fujifilm Co.).

However, the clinical impact of CAD-EYE system in improving the adenoma detection have yet to be assessed

Details
Condition Artificial Intelligence
Treatment Artificial intelligence
Clinical Study IdentifierNCT05139186
SponsorIstituto Clinico Humanitas
Last Modified on17 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

patients aged 45 or older undergoing average risk colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)

Exclusion Criteria

subjects with personal history of CRC, or IBD
subjects affected with Lynch syndrome or Familiar Adenomatous Polyposis
patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale < 2 in any colonic segment)
patients with previous colonic resection
patients on antithrombotic therapy, precluding polyp resection
patients who were not able or refused to give informed written consent
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