Clinical trial NCT05244278: Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
Official title: Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Artificial Intelligence
Keywords: Polyp detection
Adenoma detection
Adenoma per colonoscopy
Sessile serrated lesion detection rate
Sessile serrated lesion per colonoscopy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: McGill University
name: University of British Columbia
name: Université de Sherbrooke
name: University of Alberta
First posted: 2022-02-17
Enrollment: 1596
Sex: ALL
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic double-blinded, randomized, multi-endoscopist, multicenter
Primary purpose: DIAGNOSTIC

Brief summary: This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a Computer-assisted detection (CADe) system within the routine clinical practice of Canadian healthcare institutions.

The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.

Detailed description: This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.).

Eligible patients will be randomized (1:1) stratified per center, endoscopist, sex, and age group in two arms:

1. Intervention arm: patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CADe system.
2. Control arm: patients will undergo colonoscopy in a room not equipped with the GI genius CADe system.

The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe. Additionally, they won't be informed of the ongoing trial and will have the option of not using the CADe when available in the room. This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies.

Data will be collected on case report forms (CRF), after the procedure, from the clinical files and the endoscopy reports. The data will then be deidentified and transferred to an electronic RedCap database in each institution. A research assistant will collect all information and annotations recorded on the patient's medical file during the procedure.

In the treatment group (operating room equipped with the CADe), the Medtronic-GI genius system can be used for real-time support by the endoscopists to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used, CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.

In the control group (colonoscopy performed in room without CADe system), the participating endoscopists will detect as per standard of care.

All colonoscopies (in the intervention and control groups) including polypectomy procedures will be performed at the discretion of the treating physician and per standard of care.

All polyps will be resected as per standard of care and sent to the pathology labs of the participating institutions to be evaluated for histology by board-certified pathologists. The histopathology outcomes will be collected and stored in the CRF forms to be used as a reference later.

Eligibility criteria: Inclusion Criteria:

* indication of undergoing a screening, surveillance, or diagnostic colonoscopy
* Age 45-89 years

Exclusion Criteria:

* Patients undergoing emergency colonoscopy
* Patients with a known familial polyposis syndrome or a known inflammatory bowel disease

Primary outcomes:
measure: ADR
timeFrame: 30 days
Secondary outcomes:
measure: Mean number of adenomas per colonoscopy (APC)
timeFrame: 30 days
measure: Sessile serrated lesions (SSL) detection rate
timeFrame: 30 days
measure: Sessile serrated lesion per Colonoscopy (SSLPC)
timeFrame: 30 days
measure: Advanced lesion detection rate (ALDR)
timeFrame: 30 days
measure: Proximal ADR
timeFrame: 30 days
measure: Proportion neoplastic and non-neoplastic polyps
timeFrame: 30 days
measure: CADe utilization rate
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montréal
state: Quebec
Study officials:
References: