Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection (CUFFAID)

Hospital Universitario de Canarias

Status: Completed

Conditions: Adenoma Detection Rate

Treatments: Device: Endocuff; Device: Computed adenoma detection system (CADe) plus endocuff

Study type: Interventional

Funder types: Other

Identifiers

NCT05141773

Computer aid colonoscopy

Details and patient eligibility

About

The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system combined with endocuff compared with endocuff in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy.

The secondary aims were:

• To evaluate the benefit of Endo-AID and endocuff in adenoma detection rate by comparing endoscopists with high and low adenoma detection rate.
• To evaluate serrated detection rate, advanced adenoma detection rate, adenoma detection rate according to the size (<= 5mm, 6-9mm,> = 10mm) and number of adenomas by colonoscopy. Stratification by location and morphology.

Full description

Guidelines have been established regarding artificial intelligence (AI) applied to gastrointestinal endoscopy. Regarding the priority uses for their development, there are applications that improve vision, placing computer-assisted lesion detection (CADe) as one of the most necessary priorities, given the importance of colorectal cancer screening (CRC) and post-polypectomy surveillance. The evaluation of these systems in different clinical practices and patient groups has been recommend. In this regard, studies in the western population are limited and have been carried out by expert endoscopists. It has not been evaluated comparing with other strategies such as add-on devices. In addition, there are no studies with the recent CADe Endo-AID system (Olympus Corp. Tokyo).

The main purpose of the study is to evaluate the usefulness of the Endo-AID artificial intelligence system with endocuff in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy compared with standard colonoscopy with endocuff. In addition, the benefit of the CADe system will be assessed according to the endoscopist ADR.

A randomized controlled trial will be carried out in consecutive outpatients meeting the inclusion criteria and none of the exclusion criteria. Patients with be randomized to one of the two groups: CADe system with endocuff and standard colonoscopy with endocuff.

Enrollment: 696 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Patients referred for outpatient colonoscopy

Exclusion criteria

• Colonic resection
• Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
• Patients with a recent colonoscopy (<6 months) of good quality (e.g. cited for endoscopic therapy)
• IBD
• Patients with incomplete colonoscopy
• Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
• Patients with polyposis syndromes

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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696 participants in 2 patient groups

Computed adenoma detection system (CADe) and Endocuff

Experimental group

Description:

CADe system can detect in the screen suspicion areas of adenomatous polyps. This is an additional help for the endoscopist for the detection of lesions. Endocuff increases the colonic surface examinated

Treatment:

Device: Computed adenoma detection system (CADe) plus endocuff

Control group (Endocuff)

Active Comparator group

Description:

Endocuff increases the colonic surface examinated

Treatment:

Device: Endocuff