The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps during colonoscopy. The purpose of this prospective clinical cohort study is to evaluate the performance of the SCALE-EYE virtual scale for measuring polyp size when used during live colonoscopies. The investigators also wish to evaluate CAD-eye for detection and classification of polyp histology. It is hypothesized that CAD-eye and SCALE-EYE can function in real-time practice with high accuracy.
Detailed Description: This study will be conducted in several phases: phase 1 will evaluate the feasibility of using CAD-eye in real-time practice, training endoscopists to work with this platform, obtaining preliminary data on relative size measurement accuracy when using scale eye, testing feasibility of fresh polyp specimen size measurement and determining the sample size and reference standard for evaluating SCALE-EYE during the subsequent phases of the study in randomized controlled trials. Phase 2 will evaluate relative size measurement accuracy of SCALE-EYE compared to visual size estimation and CADe/CADx performance in a randomized controlled trial. Scale-eye will further be validated through video-based analysis comparing different size measurement methods (scale eye, snare, forceps, visual assessment) with different groups of endoscopists (experts, staff gastroenterologists, trainees evaluating videos showing video sequences that show the polyps either with scale eye, visual or instrument information. Furthermore, fresh specimen size measurement and pathology-based size (including different ways to prepare specimens for pathology sectioning) will be evaluated for agreement between size measurement methods and tissue shrinkage effects. Phase 3 will evaluate relative size measurement accuracy of SCALE-EYE compared to snare-based size estimation. Eligible patients will be adults (aged 45 to 80 years) referred to CHUM for diagnostic, screening or surveillance colonoscopy. Patients will undergo colonoscopies using CAD-eye, and the size of all polyps detected will be estimated by different subjective and objective methods. All polyp size measurements will be videorecorded. Video recordings with different measurement instruments (forceps, snare, scale eye, visual assessment) will be assessed with different groups of endoscopists (experts, staff gastroenterologists, trainees) for size measurements through online video presentations in a randomized order. The main results of this study are to evaluate the relative accuracy of SCALE-EYE for polyp size estimation and the adenoma detection rates, sensitivity, specificity, NPV for CAD-eye for polyp detection and classification. We will also calculate other characteristics of CAD-eye and SCALE-EYE tests, the rate of divergence and/or agreement between subjective and objective methods of polyp size estimation, the agreement between surveillance intervals based on optical diagnosis by CAD-eye and pathological findings, and the false positive rate and latency for polyp detection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
348
Detection and classification and size measurement of polyp by Artificial Intelligence (CADeye) and Scale Eye This study will be conducted in multiple phases: phase 1 (pilot phase, n=40 polyps, about 60 patients) to evaluate the feasibility of applying Scale Eye in real-time practice, training endoscopists to work with CADe and CADx and determining the sample size and reference standard to evaluate SCALE-EYE during the second phase of the study (randomized controlled trial), phase 2 will evaluate the performance of SCALE-EYE and CAD-eye in real-time practice. The sample size for phase 2 (RCT comparing visual with scasle eye) will be based on the pilot data allowing to compare relative accuracy of size measurement with scale eye versus visual size estimation. After completion of phase 2 later phases will use instruments such as snare and/or forceps as reference measurement devices compared to relative accuracy of measurement when using scale eye.
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada
Evaluation of the Scale-Eye
to compare the relative accuracies of SCALE-EYE size measurement, visual size estimation or size estimation based on a standard polypectomy snare for colorectal polyps during real-time colonoscopies with measurement of viable specimens by a Vernier caliper as reference standard. Relative accuracy is defined as "1-\[(ScaleEye measurement - gold standard measurement)/gold standard measurement\] x100". Scale: 0-100. Higher score is a better outcome.
Time frame: 30 days
Evaluation of CADe function
compare the adenoma detection rate between the CAD-eye-assisted colonoscopy and standard colonoscopy (i.e., detecting adenomas only by endoscopists)
Time frame: 30 days
Evaluation of CADx function
evaluate the accuracy, sensitivity, specificity, positive and negative predictive value of CADx for classifying 1-5 mm polyp histology into neoplastic and non-neoplastic compared with the histopathology outcomes as the reference standard
Time frame: 30 days
Agreement and discrepancy between SCALE-EYE and other measurement
calculate the agreement and discrepancy between SCALE-EYE and other measurement methods
Time frame: 30 days
Video-based assessments
compare in video-based assessments with different endoscopists (expert level, staff GI, surgeons, trainees the relative size measurements accuracy of scale eye with visual and instrument based (snare and/or forceps) size measurement accuracy
Time frame: 30 days
CADe sensitivity in polyp detection
evaluate the sensitivity of the CAD-eye in combination with adjunct methods for real-time detecting colorectal polyps compared with standard colonoscopy
Time frame: 30 days
CADe function: proportion of polyps detected
to evaluate the proportion of polyps detected by the CAD-eye in combination with adjunct methods
Time frame: 30 days
Evaluation of CADx function
compare the accuracy, sensitivity, specificity, positive and negative predictive value of CADx for classifying 1-5 mm polyp histology to that of using human decision based on CADx suggestion
Time frame: Through study completion, estimation: 3 months
CADx proportion of polyp histology non-evaluable
calculate the proportion of 1-5 mm polyps, CADx can not suggest histology (in the intervention arm, please refer to the randomization section), while endoscopists can suggest histology with high confidence, or vice versa
Time frame: 30 days
CADx diagnostic uncertainty
evaluate diagnostic uncertainty of the current CADx module when predicting the pathology of colorectal polyps
Time frame: 30 days
3D scanning assessment
evaluation of the relative accuracy of 3D scanned polyps compared to measurement of viable specimens by a Vernier caliper as reference standard. Relative accuracy is defined as "1-\[(ScaleEye measurement - gold standard measurement)/gold standard measurement\] x100". Scale: 0-100. Higher score is a better outcome.
Time frame: 30 days
Histologic size assessment
evaluation of the relative accuracy of histologic size measurement compared to measurement of viable specimens by a Vernier caliper as reference standard. Relative accuracy is defined as "1-\[(ScaleEye measurement - gold standard measurement)/gold standard measurement\] x100". Scale: 0-100. Higher score is a better outcome.
Time frame: 30 days
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