Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital (Delta-AI)

Chirec

Status: Not yet enrolling

Conditions: Colonic Polyp; Colonic Neoplasms; Artificial Intelligence; Colonoscopy; Colonic Adenoma

Treatments: Other: artificial intelligence-assisted colonoscopy procedure; Other: conventional colonoscopy procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06792292

2024 Chirec Delta Colo-AI

Details and patient eligibility

About

Cancer can develop in the colon, or large bowel. Examination of the colon with a tube fitted with a camera is called a colonoscopy.

Colonoscopy allows detection of small growths in the colon, called "polyps". Polyps can often be removed during colonoscopy. Some of these polyps are called adenomas and can become cancer after several years.

A good colonoscopy aims to find and take out as many of these polyps as possible.

A quality indication of colonoscopy is the "adenoma detection rate" (ADR). It should be high, meaning many polyps are detected and taken out.

New artificial intelligence devices to assist colonoscopy seem to increase the ADR, and maybe help prevent cancer even better than normal colonoscopy.

The goal of this clinical trial is to compare the ADR when using standard colonoscopy to the ADR with artificial intelligence (AI)-assisted colonoscopy.

Full description

The colon is a part of the bowel where colon cancer can develop.

It is possible to prevent colon cancer by doing a screening test called a colonoscopy.

The colonoscopy procedure allows detection of "polyps" which can often be removed during the procedure. Some of these polyps are called adenomas and can become cancer after several years.

A good colonoscopy aims to find and take out as many of these polyps as possible.

A quality indication of colonoscopy is the "adenoma detection rate" (ADR). It should be high, meaning many polyps are detected and taken out.

New artificial intelligence devices to assist colonoscopy seem to increase the ADR, and maybe help prevent cancer even better than normal colonoscopy.

The goal of this clinical trial is to compare the ADR when using standard colonoscopy to the ADR with artificial intelligence (AI)-assisted colonoscopy.

Patients who are scheduled to have screening colonoscopy and who agree to participate, and are aged 45 years or more, will be randomly assigned to receive either standard colonoscopy or AI-assisted colonoscopy.

The main objective of this study is the difference in the ADR between a conventional colonoscopy procedure and an AI-assisted colonoscopy procedure.

Secondary objectives will compare the 2 groups (conventional colonoscopy and AI-assisted colonoscopy) regarding polyp size, polyp quantity, polyp histology (laboratory analysis of the polyp that was taken out), polyp dysplasia grade (how close the polyp is to cancer), polyp location in the colon, endoscopist experience (older or younger doctor), time of day and colonoscopy preparation quality (how clean the bowel is).

With these results we can show that AI-assisted colonoscopy is useful or not to help better prevent colon cancer.

Enrollment: 765 estimated patients

Sex: All

Ages: 45 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient (woman or man) candidate for a screening colonoscopy - Age: 45 to 74 years included
• Absence of inflammatory bowel disease
• Absence of significant digestive symptoms indicating colonoscopy (i.e. screening is the only indication for the examination)
• Patient able to understand the concept of the study and agreeing to participate

Exclusion criteria

• Patient outside the inclusion age
• All exclusion criteria for a colonoscopy.
• The indication for colonoscopy is not simple screening; for example, assessment of anemia, rectal bleeding, weight loss or abdominal pain.
• Patient's refusal to participate, or patient's inability to understand the study concept
• Any patient with major psychological or psychiatric disorders.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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765 participants in 2 patient groups

CCP: conventional colonoscopy procedure

Active Comparator group

Description:

The conventional colonoscopy arm subjects will undergo a screening colonoscopy without assistance from artificial intelligence.

Treatment:

Other: conventional colonoscopy procedure

ACP: artificial intelligence-assisted colonoscopy procedure

Active Comparator group

Description:

The artificial intelligence-assisted colonoscopy arm subjects will undergo a screening colonoscopy with assistance from an artificial intelligence module.

Treatment:

Other: artificial intelligence-assisted colonoscopy procedure