Development of a Computer-aided Polypectomy Decision Support

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04811937

Collaborator

(none)

605

Enrollment

Location

Arm

Anticipated Duration (Months)

25.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Quality components of colonoscopy include the detection and complete removal of colorectal polyps, which are precursors to CRC. However, endoscopic ablation may be incomplete, posing a risk for the development of "interval cancers". The investigator propose to develop a solution based on artificial intelligence (AI) (CADp computer-aided decision support polypectomy) to solve this problem.This research project aims to develop CADp, a computer decision support solution (CDS) for the ablation of colorectal polyps from 1 to 20 mm.

Condition or Disease	Intervention/Treatment	Phase
Adenomatous Polyps	Diagnostic Test: Computer-aided polypectomy decision support by Artificial Intelligence	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

605 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Development of a Computer-aided Polypectomy Decision Support

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artificial intelligence for real-time Computer decision support of resection of colorectal polyps A standard colonoscopy will be performed according to the standard of routine care. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. The AI system will capture video of the procedure in real time, and provide additional information about polypectomy procedures.	Diagnostic Test: Computer-aided polypectomy decision support by Artificial Intelligence The AI system will capture the live video of the procedure and the AI feedbackwill be shown on a second screen installed next to the regular endoscopy screen. Screen A will show the regular endoscopy image and screen B will show the regular endoscopy image together with the areas that might harbor a polyp and the information to help the polypectomy.

Arm

Intervention/Treatment

Experimental: Artificial intelligence for real-time Computer decision support of resection of colorectal polyps

A standard colonoscopy will be performed according to the standard of routine care. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. The AI system will capture video of the procedure in real time, and provide additional information about polypectomy procedures.

Diagnostic Test: Computer-aided polypectomy decision support by Artificial Intelligence

The AI system will capture the live video of the procedure and the AI feedbackwill be shown on a second screen installed next to the regular endoscopy screen. Screen A will show the regular endoscopy image and screen B will show the regular endoscopy image together with the areas that might harbor a polyp and the information to help the polypectomy.

Outcome Measures

Primary Outcome Measures

Accuracy of the CADp system [3 weeks]
accuracy with which the CADp system predicts completeness of polypectomy in the test set with the reference standard for completeness being determined by the histology of post-polypectomy margin biopsies; if free from any polyp tissue (adenomatous, serrated or hyperplastic), the resection will be considered complete. If remnant polyp tissue is detected in any one or more of the margin biopsies the resection is deemed incomplete
Completeness of polypectomy [1 month]
We will evaluate the agreement between the different subjective and objective ways of assessing the completeness of the polypectomy : evaluation of margins (presence or not, measurement of margins) by endoscopists self-assessment, and by expert consensus.
Training CADp [1 month]
Evaluation of the concordance of data on polyp size, extension of margins around the polyp, quality of resection between clinical data (endoscopists' self-assessment and experts' assessments) and CADp prediction.
Validity of the choice of primary outcome [1 month]
Based on the results and comparison of the different assessment methods, we will perform sensitivity analyses to assess the validity and robustness of the choice of primary outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent
Age 45-80 years
Indication to undergo a lower GI endoscopy.

Exclusion Criteria:

Known inflammatory bowel disease
Active colitis
Coagulopathy
Familial polyposis syndrome;
Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3
Emergency colonoscopies