AIChallengeMed: Comparison of Flat Colorectal Lesion Detection by Artificial Intelligence-assisted Colonoscopy Versus Endoscopists

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05942677
Collaborator
(none)
160
1
18.9
8.5

Study Details

Study Description

Brief Summary

The development of artificial intelligence (AI) systems in the field of colorectal endoscopy is currently booming, colorectal cancer being, by its frequency and severity, a real public health problem.

In terms of image analysis, AI is indeed able to perform many tasks simultaneously (lesion detection, classification, and segmentation) and to combine them.

Lesion detection is thus the starting point of the whole chain to choose at the end the most appropriate treatment for the patient. Large-scale studies have demonstrated the superiority of artificial intelligence-assisted detection over the usual detection by gastroenterologists, mainly for the detection of sub-centimeter polyps.

However, the investigators have shown that a recent computer-aided detection system (CADe) such as the ENDO-AID software in combination with the EVIS X1 video column (Olympus, Tokyo, Japan) may present difficulties in the detection of flat lesions such as sessile serrated lesions (SSLs) and non-granular laterally spreading tumors (LST-NGs).

This represents a major challenge because in addition to their shape being difficult to identify for the human eye in practice and where AI assistance would be of great value, these rare lesions are associated with advanced histology.

In addition, the investigators recently described the case of a worrisome false negative of AI-assisted colonoscopy, which failed to detect a flat adenocarcinoma in the transverse colon.

Therefore, it is important to measure the false negative rate of AI detection based on the macroscopic shape of the lesion. Comparing this rate to the human endoscopist's false negatives would improve the performance of AI for this specific lesion subtype in the future.

Condition or Disease Intervention/Treatment Phase
  • Procedure: proportion of colorectal lesions

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Flat Colorectal Lesion Detection by Artificial Intelligence-assisted Colonoscopy Versus Endoscopists: AIChallenge - Medtronic
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Colorectal lesion diagnostic

Every patient referred to our center for colorectal endoscopy for investigation and/or resection of colorectal lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists.

Procedure: proportion of colorectal lesions
Evaluation of the proportion of colorectal lesions detected by a computer-aided detection system (CADe) compared with experienced endoscopists.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the proportion of colorectal lesions [Time point can be reached either 2 weeks after endoscopic resection or between 2-4 months later in case of surgery]

    Evaluation of the proportion of colorectal lesions detected by a computer-aided detection system (CADe) compared with experienced endoscopists and correlation with final histology reading.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • both gender patients even or older than 18 years old

  • patient with French Health Insurance coverage

  • obtaining of oral non opposition to research after loyal, clear and complete delivery of information

  • patients addressed to our center for colorectal lesion resection

  • patients presenting a colorectal lesion discovered during a diagnostic colonoscopy

Exclusion Criteria:
  • patients with health disorders needing short procedure times

  • patients with no colorectal lesion

  • difficulty continuing colonoscopy due to poor sedation

  • difficulty continuing colonoscopy due to a serious adverse event

  • inappropriate participation after colonoscopy is completed

  • unwillingness to participate after colonoscopy is completed

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Edouard Herriot Lyon France 69437

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05942677
Other Study ID Numbers:
  • 69HCL21_1366
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 13, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon

Study Results

No Results Posted as of Jul 13, 2023