Study Comparing the Contribution of G-Eye Combined With CAD-Eye Versus High-definition Colonoscopy With CAD-Eye in the Detection of Colonic Lesions After a Positive Immunological Test in the Context of Organized Colorectal Cancer (BENEFIT)

Elsan

Status: Completed

Conditions: Colo-rectal Cancer; Colorectal Cancer

Treatments: Procedure: Colonoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT07502469

BENEFIT

Details and patient eligibility

About

The incidence of colorectal cancer (CRC) is high in France, with approximately 45,000 new cases per year. The fecal immunochemical test (FIT) is used for screening for this cancer. If the test is positive, a colonoscopy is recommended.

In recent years, French and European societies of digestive endoscopy have defined quality criteria for colonoscopy to reduce the risk of interval colorectal cancer (ICRC), that is, CRC occurring within 5 years of a colonoscopy considered negative. The operator's adenoma detection rate (ADR) is one of these factors. Its threshold is set at 45% within the framework of the organized CRC screening program, i.e., after a positive FIT.

Artificial intelligence is emerging as an effective way to increase operators' ADR. Balloon-assisted endoscopy (G-Eye) also increases the TDA (transient anaerobic digestion).

No French data are available regarding G-Eye, and there is limited data concerning CAD-Eye (artificial intelligence). No data exist on the combination of these two devices. Therefore, there is no data on the combination of these devices during a colonoscopy performed after a positive TIF (transient anaerobic digestion) test.

It should be noted that all published studies were conducted in expert centers. The value of this study lies in its ability to collect real-world data.

Enrollment: 341 patients

Sex: All

Ages: 50 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fecal Immunological Test positive
• Age between 50 and 74 years
• Colonoscopy performed between November 1, 2021 and June 30, 2024
• Patient informed about the use of their health data

Exclusion criteria

• High or very high risk of colorectal cancer (CRC) (inflammatory bowel disease, identified genetic predisposition to CRC, personal history of CRC, advanced adenoma < 10 years, first-degree family history of CRC < 60 years)
• Patient < 50 years and > 74 years
• Patient opposed to the reuse of their health data

Trial design

341 participants in 2 patient groups

Colonoscopy performed in high-definition white light with CAD-Eye

Treatment:

Procedure: Colonoscopy

Colonoscopy performed with the combined use of AI/balloon (CAD-Eye/G-Eye)

Treatment:

Procedure: Colonoscopy