Diagnostic Performance of a Convolutional Neural Network for Diminutive Colorectal Polyp Recognition
- Conditions
- Artificial IntelligenceColorectal Polyp
- Interventions
- Device: CAD-CNN system
- Registration Number
- NCT03822390
- Brief Summary
Rationale: Diminutive colorectal polyps (1-5mm in size) have a high prevalence and very low risk of harbouring cancer. Current practice is to send all these polyps for histopathological assessment by the pathologist. If an endoscopist would be able to correctly predict the histology of these diminutive polyps during colonoscopy, histopathological examination could be omitted and practise could become more time- and cost-effective. Studies have shown that prediction of histology by the endoscopist remains dependent on training and experience and varies greatly between endoscopists, even after systematic training. Computer aided diagnosis (CAD) based on convolutional neural networks (CNN) may facilitate endoscopists in diminutive polyp differentiation. Up to date, studies comparing the diagnostic performance of CAD-CNN to a group of endoscopists performing optical diagnosis during real-time colonoscopy are lacking.
Objective: To develop a CAD-CNN system that is able to differentiate diminutive polyps during colonoscopy with high accuracy and to compare the performance of this system to a group of endoscopist performing optical diagnosis, with the histopathology as the gold standard.
Study design: Multicentre, prospective, observational trial. Study population: Consecutive patients who undergo screening colonoscopy (phase 2)
Main study parameters/endpoints: The accuracy of optical diagnosis of diminutive colorectal polyps (1-5mm) by CAD-CNN system compared with the accuracy of the endoscopists. Histopathology is used as the gold standard.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 292
All patients older than 18 years old undergoing screenings colonoscopy in one of the participating centres.
- Diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposis syndrome.
- Boston Bowel Preparation Scale (BBPS) <2 in one of the colon segments
- Patients who are unwilling or unable to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients CAD-CNN system Patients older than 18 years undergoing colonoscopy in one the participating centres.
- Primary Outcome Measures
Name Time Method The accuracy of the CAD-CNN system for predicting histology of diminutive colorectal polyps (1-5mm) compared with the accuracy of the prediction of the endoscopist. Both the CAD-CNN system and the endoscopist will use NBI for their predictions. 2 year Accuracy is defined as the percentage of correctly predicted optical diagnoses of the CAD-CNN system and / or endoscopist compared to the gold standard pathology. For the calculation of the accuracy, adenomas and SSLs will be dichotomized as neoplastic polyps, while HPs are considered non-neoplastic
- Secondary Outcome Measures
Name Time Method The number of diminutive polyps per colonoscopy that is resected and discarded without histopathological analysis with optical diagnosis strategy (the CAD-CNN system or endoscopist) 2 year The number of diminutive polyps per colonoscopy that is resected and discarded without histopathological analysis with optical diagnosis strategy (the CAD-CNN system or endoscopist)
The percentage of colonoscopies in which the surveillance interval is based on the optical diagnosis of the CAD-CNN system and the patient can be directly informed of the surveillance interval after colonoscopy 2 year The percentage of colonoscopies in which the surveillance interval is based on the optical diagnosis of the CAD-CNN system and the patient can be directly informed of the surveillance interval after colonoscopy
The diagnostic sensitivity for optical diagnosis of the CAD-CNN system and the endoscopists 2 year The diagnostic sensitivity for optical diagnosis of the CAD-CNN system and the endoscopists
Agreement between recommended surveillance intervals, based on optical diagnosis of diminutive polyps with high confidence, compared to surveillance recommendations based on histology of all polyps 2 year Agreement between recommended surveillance intervals, based on optical diagnosis of diminutive polyps with high confidence, compared to surveillance recommendations based on histology of all polyps
The mean duration in seconds of the CAD-CNN system to make a per polyp diagnosis. 2 year The mean duration in seconds of the CAD-CNN system to make a per polyp diagnosis.
The accuracy rates on a per polyp basis 2 year Accuracy on a polyp basis is defined as the percentage of correctly predicted optical diagnoses of the CAD-CNN system and / or endoscopist compared to the gold standard pathology. For the calculation of the accuracy on a polyp basis, adenomas, SSLs and HPs are considered different subtypes.
The diagnostic NPV for optical diagnosis of the CAD-CNN system and the endoscopists 2 year The diagnostic NPV for optical diagnosis of the CAD-CNN system and the endoscopists
The ratio of unsuccessful diagnosis from all diagnosis of the CAD-CNN system. An unsuccessful diagnosis/failure of the CAD-CNN system is defined as more than 3 unsuccessful attempts 2 year The ratio of unsuccessful diagnosis from all diagnosis of the CAD-CNN system. An unsuccessful diagnosis/failure of the CAD-CNN system is defined as more than 3 unsuccessful attempts
The percentage of colonoscopies in which diminutive hyperplastic polyps in the rectosigmoid are left in situ. 2 year The percentage of colonoscopies in which diminutive hyperplastic polyps in the rectosigmoid are left in situ.
The diagnostic sensitiviy for optical diagnosis of the CAD-CNN system and the endoscopists 2 year The diagnostic sensitiviy for optical diagnosis of the CAD-CNN system and the endoscopists
The diagnostic specificity for optical diagnosis of the CAD-CNN system and the endoscopists 2 year The diagnostic specificity for optical diagnosis of the CAD-CNN system and the endoscopists
The diagnostic PPV for optical diagnosis of the CAD-CNN system and the endoscopists 2 year The diagnostic PPV for optical diagnosis of the CAD-CNN system and the endoscopists
The mean number of attempts of the CAD-CNN to make a diagnosis per polyp 2 year The mean number of attempts of the CAD-CNN to make a diagnosis per polyp
The percentage of colonoscopies in which diminutive polyps are characterized based on optical diagnosis, removed and discarded without histopathological evaluation (i.e. proportion of polyps assessed with high confidence) 2 year The percentage of colonoscopies in which diminutive polyps are characterized based on optical diagnosis, removed and discarded without histopathological evaluation (i.e. proportion of polyps assessed with high confidence)
Trial Locations
- Locations (1)
Academic Medical Centre
🇳🇱Amsterdam, Noord-Holland, Netherlands