Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection (AIRCOP)

January 22, 2024 updated by: TANNOURY Jenny, Groupe Hospitalier Diaconesses Croix Saint-Simon

Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection: a Randomized Controlled Trial

The aim of the study is to assess whether the use of artificial intelligence improves polyp detection in a segment of the colon (the right colon).

To achieve this objective, patients will be divided into two groups: one will undergo a standard colonoscopy, the other a colonoscopy with the artificial intelligence software connected to the machine.

This software does not modify the colonoscopy technique in any way, and does not require the administration of any product to the patient.

The study will compare the detection rate of right colon polyps between the group of patients who underwent standard colonoscopy and those who underwent colonoscopy with artificial intelligence. If this number does not differ between the two groups, the investigators can conclude that there is no point in using artificial intelligence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer (CRC) is the third most common cancer and remains one of the leading causes of mortality among neoplastic diseases in the world. Screening colonoscopy with detection and resection of colorectal polyps have reduced CRC incidence and mortality.

Nevertheless, colonoscopy is an imperfect screening test and its effectiveness is influenced by a range of variables including the skill and expertise of the endoscopist. Indeed, a significant proportion of colorectal neoplasia is missed during colonoscopic examinations. In the majority of studies, the rate of interval CRC among all CRCs ranged from 2% to 9% and interval cancers occurred more likely in the right colon. Interval cancers can result from missed lesion, incomplete removal or newly developed cancer. Most missed polyps are smaller than 10 mm in diameter and are sessile or flat in appearance. Therefore, sessile serrated adenomas (SSAs), which predominantly occur in the right colon, are easily missed because they are small and sessile.

Colonoscopy is less effective in screening right sided CRCs, mainly because of the increased miss rate for polyps with sessile or flat appearance. In recent years, artificial intelligence (AI) is increasingly applied in gastrointestinal endoscopy, especially in the detection of colorectal polyps. In 2019, the first prospective randomized controlled trial including 1058 patients and comparing the polyp detection rate in colonoscopy with or without AI showed a significantly higher detection rate in the group with AI (29.1% vs 20.3%). Other previous prospective studies have showed that AI had great potential for improving colonic polyp detection.

To our knowledge, this is the first study to date to evaluate the performance of the AI in the detection of right colon polyps.

In this study, the investigators aim first of all to compare the rate of right colon polyp detection with AI-aided colonoscopy (AIC) to the rate obtained by the Standard (high-definition) colonoscopy (SC) in patient undergoing diagnostic colonoscopy. Then, the investigators would to evaluate the following endpoints:

  1. Comparison of time required for AIC versus SC (withdrawal time)
  2. Comparison of histological classification of all polyps detected in each group
  3. Comparison of the number of right colon polyps detected in each group
  4. A subgroup analysis comparing the rate of colon polyp detection between the two groups will be realized according to the procedure starting time (accounting for operator fatigability).

Study Type

Interventional

Enrollment (Actual)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75020
        • Groupe Hospitalier Diaconesses Croix Saint-Simon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age>18 years
  • Signed informed consent
  • Affiliated to or beneficiary of a social security scheme

Exclusion Criteria:

  • Patients with history of inflammatory bowel diseases
  • Patients with history of familial polyposis syndrome
  • Patients with history of right colonic resection.
  • Pregnant or breastfeeding women
  • Patient benefiting from a legal protection measure : tutorship, curatorship, patient deprived of freedom
  • Adults who are unable to give their consent
  • People under psychiatric care who are not able to understand the aim if this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-aided colonoscopy
Experimental arm : patients receive a colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA)
Procedure: Colonoscopy
Colonoscopy
Active Comparator: Standard colonoscopy
Control arm :The artificial intelligence is not activated during the colonoscopy exam,the patient receive a standard high definition colonoscopy
Procedure: Colonoscopy
Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale, for the operator, for the endoscope and for stratification factors.
Time Frame: Inclusion visit
A multiple logistic regression comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale (6-7 vs >7), for the operator, for the endoscope (Pentax or Fuji) and for stratification factors (age and polyps or CRC history).
Inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Collaborators

Cosmo Artificial Intelligence-AI Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

December 12, 2023

Study Completion (Actual)

January 3, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01243-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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