Artificial Intelligence in the Characterization of Colorectal Polyps

NCT04749277 | Completed

• 1 other identifier: CHUCoimbra
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

Current guidelines recommend resection and histopathological analyses of all colorectal polyps. Real-time optical diagnosis can obviate non-neoplastic polyp resection ("diagnose-and-leave-behind") and histopathological analyses of diminutive polyps ("predict-resect-and-discard") reducing healthcare and cost burden. The investigators aimed to evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE® (Fujifilm,Germany) in real-time optical characterization of colorectal polyps compared to endoscopic diagnosis with histopathology as the gold-standard. For this purpose, a single-centre prospective study of diminutive/small colorectal polyps is ongoing.

Conditions

Colonic Polyps

Keywords

Artificial Intelligence; Colonoscopy; Colonic Polyps

Outcome Measures

Primary Outcomes (2)

• Real-time optical characterization of colorectal polyps (CAD EYE® versus Histopathology)

  To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE® system in real-time optical characterization of colorectal polyps by comparison with histopathological analysis

  2 months

• Real-time optical characterization of colorectal polyps (Endoscopist versus Histopathology)

  To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE® system in real-time optical characterization of colorectal polyps compared to digital chromoendoscopy by endoscopists

  2 months

Secondary Outcomes (4)

• Real-time optical characterization of colorectal polyps according to polyps size

  2 months

• Real-time optical characterization of colorectal polyps according to polyps location

  2 months

• Real-time optical characterization of colorectal polyps according to polyps histological type

  2 months

• Real-time optical characterization of colorectal polyps according to endoscopist experience

  2 months

Study Arms (2)

Endoscopist characterization on WLI and BLI modes

Optical characterization of an identified polyp, first in WLI and then in BLI mode, with CAD EYE® OFF. This evaluation should be systematically performed by two independent endoscopists in the exam room, preferably (but not necessarily) an experienced endoscopist and a trainee. The presence of at least one experienced endoscopist is mandatory. An independent evaluation is guaranteed. First step - The 1st endoscopist (who performing colonoscopy) request the polyp evaluation and record written by the 2nd endoscopist (who not performing the colonoscopy) - blinded evaluation since 1st endoscopist doesn't verbalize his evaluation); 2nd step - when the 2nd endoscopist signals that he completed his record, the 1st endoscopist verbally explicit his classification, which is recorded by the 2nd endoscopist. This evaluation should include polyp histological type (hyperplastic, adenoma, sessile serrated lesion or other type) and the level of confidence of the evaluation performed (high or low).

CAD EYE® characterization on BLI mode

Optical characterization mode of CAD EYE® (CAD EYE® ON) in BLI mode should be activated for the evaluation of CAD EYE® optical characterization, in hyperplastic or neoplastic polyps, as well as the level of characterization (graduated from 1 to 3). The evaluation of the CAD EYE® should also be recorded by the endoscopist in the exam room who is not performing the colonoscopy, on its own record sheet. The iconographic record of evaluated polyps in WLI and BLI modes and the evaluation video using CAD EYE® in BLI characterization mode should be done.

Other: CAD EYE® (Fujifilm, Europe, Gesellschaft mit beschränkter Haftung, Dusseldorf, Germany)

Interventions

CAD EYE® (Fujifilm, Europe, Gesellschaft mit beschränkter Haftung, Dusseldorf, Germany) OTHER

Methods plan Phase 1. Brief virtual chromoendoscopy training on the characterization of colorectal polyps (WLI, LCI and BLI) Phase 2. CAD EYE® system applied during colonoscopy retrieval: 2.1. CAD EYE® system OFF: Virtual chromoendoscopy (BLI) - independently characterization of a suspected polyp in WLI and BLI by the first endoscopist and by the second endoscopist (iconographic record) 2.2. CAD EYE® system ON: Characterization mode (BLI): Characterization of a suspected polyp by CAD EYE® and respectively level of characterization (1 to 3) (iconographic record) Phase 3. Histopathological evaluation (pathologist with gastrointestinal expertise): Resection and recovery of a suspected polyp for anatomopathological characterization

CAD EYE® characterization on BLI mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The total number of consecutive patients who underwent elective colonoscopy with high quality of bowel preparation (at least two points per segment and at least of six points at the total score of Boston Bowel Preparation), performed at the Gastroenterology Department of the Centro Hospitalar e Universitário de Coimbra, E.P.E., Coimbra, Portugal, with at least one identified colorectal polyp, regardless the indication for its performance.

You may qualify if:

• Age ≥18 years;
• The presence of at least one polyp in an elective colonoscopy.

You may not qualify if:

• Poor bowel preparation (Boston Bowel Preparation Score \<6 at the total score or \<2 at one of colorectal segment);
• No recovery of excised polyps for histopathological analysis;
• The presence of polyps not amenable to endoscopic excision or with contraindication for their excision at the time of colonoscopy;
• The absence of explicit indication for colonoscopy.

Sponsors & Collaborators

• Unidade Local de Saúde de Coimbra, EPE: lead

Study Sites (1)

Centro Hospitalar e Universitário de Coimbra

Coimbra, 3000-075, Portugal

Location

Related Publications (19)

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Related Links

• World Health Organization International Agency for Research on Cancer (IARC). Global Cancer Observatory 2018: estimated cancer incidence and mortality worldwide in 2018. \[homepage on the internet\]. Available from: https://gco.iarc.fr
• CAD EYE® (Fujifilm,Germany)
• CAD EYE® (Fujifilm,Germany)
• CAD EYE® (Fujifilm,Germany)
• CAD EYE® (Fujifilm,Germany)

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colorectal polyps

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisa Gravito-Soares, MD

  Unidade Local de Saúde de Coimbra, EPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 11, 2021
• Study Start: January 1, 2021
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)