Clinical trial NCT05492656: Accuracy of CADx System for White Light Colonic Polyp Characterization
Official title: Accuracy and Feasibility of CADx System for White Light Colonic Polyp Characterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Polyp
Adenoma Colon
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adults (18-85 years) outpatients referred for colonoscopy are invited to participate in the present study.

Brief summary: The endoscopist performances in the optical diagnosis (OD) of colonic polyps with the available technologies vary widely across centers and across endoscopists. The OD process is strictly related to the operator training and expertise. Most of the available studies in optical characterization have been carried out by expert endoscopist in tertiary high volume centers, and weren't replied on large unselected populations. For these reasons, at the moment the optical characterization of polypoid lesions can't replace, in the everyday clinical practice, the histopathological evaluation of resected polyps. Artificial intelligence (AI)-based systems have the potential to make optical characterization process of colonic polyps easier and more reliable, thus supporting the endoscopist in the application of leave-in-situ and of resect-and-discard strategies. The implementation of such strategies would lead to a significant economic saving and a decrease of risks and complications related to unnecessary polypectomy. GI-Genius System (Medtronic Inc, Minneaopolis, USA) is a CNN-based algorithm allowing an automatic OD of colonic polyps. This system does not require dedicated light setting for polyp evaluation as it works with white light high definition images, which are the actual standard in every endoscopic unit. During colonoscopy, when a polyp is framed within the screen, a green detection box surrounds the polyp and the system automatically provides (whenever possible) the optical diagnosis labeling the polyp as "adenoma or non-adenoma". When the automatic polyp charaterization is unfeasible the label "no prediction" appears. Nowadays only few data about the feasibility and performances of this system in clinical practice are available. In addition published studies are mostly focused on technical rather thann clinical issues. The present prospective observational trial is primarily aimed at evaluating the diagnostic accuracy of optical characterization of colonic polyps \<= 1 cm using GI-Genius System in daily clinical practice, having histopathology examination as reference standard.


Eligibility criteria: Inclusion Criteria:

Consecutive outpatients undergoing colonoscopy for one of the following indication:

* FIT-based screening program
* voluntary screening
* post-polipectomy surveillance
* gastrointestinal symptoms
* family history of colorectal cancer.

Exclusion Criteria:

* urgent colonoscopy
* patients in which polyps could not be resected (e.g ongoing anticoagulation therapy)
* patients with past colorectal cancer or polyposis syndrome

Primary outcomes:
measure: Diagnostic accuracy of CADx in evaluating small colonic polyps
timeFrame: Entire study duration (3 months)
Secondary outcomes:
measure: Feasibility of CADx in evaluating small colonic polyps
timeFrame: Entire study duration (3 months)
measure: Sensitivity
timeFrame: Entire study duration (3 months)
measure: specificity
timeFrame: Entire study duration (3 months)
measure: Positive predictive value
timeFrame: Entire study duration (3 months)
measure: Negative predictive value
timeFrame: Entire study duration (3 months)
Other outcomes:
Locations:
city: Como
country: Italy
facility: Gastroenterology Unit, Valduce Hospital
Study officials:
References: