Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749277
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2021-01-31
Brief Title:
Artificial Intelligence in the Characterization of Colorectal Polyps
Sponsor:
Centro Hospitalar e Universitário de Coimbra EPE
Organization:
Centro Hospitalar e Universitário de Coimbra EPE
Study Overview
Official Title:
Artificial Intelligence in the Characterization of Small and Diminutive Colorectal Polyps A Prospective Study in a Clinical Setting Using CAD EYE
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Current guidelines recommend resection and histopathological analyses of all colorectal polyps Real-time optical diagnosis can obviate non-neoplastic polyp resection diagnose-and-leave-behind and histopathological analyses of diminutive polyps predict-resect-and-discard reducing healthcare and cost burden The investigators aimed to evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE FujifilmGermany in real-time optical characterization of colorectal polyps compared to endoscopic diagnosis with histopathology as the gold-standard For this purpose a single-centre prospective study of diminutivesmall colorectal polyps is ongoing
Detailed Description:
Introduction Worldwide colorectal cancer CRC is the 4th most frequent cancer and the 3rd cause of cancer-related death In Portugal CRC is the 3rd most common cause and the 2nd leading cause of cancer-related mortality In colorectal carcinogenesis colorectal polyps adenomatous or serrated polyps are considered premalignant lesions The detection of colorectal polyps and subsequent resection is effective in reducing CRC incidence and mortality and the risk of interval CRC and is the crucial aspect of CRC prevention Considering the detection of colorectal polyps there is a wide variation among endoscopists in terms of skills for the detection of adenomas the major premalignant lesions of CRC translated into the detection rate of adenomas ADR ADR is considered a marker of careful inspection of colorectal mucosa translating quality in colonoscopy which is inversely associated with the risk of interval CRC or cancer-related death In the context of screening colonoscopy the minimum ADR is 25 to reduce the risk of interval CRC and death being predictably higher if a positive fecal occult blood test is found although the exact value still remains to be elucidated The detection rate of serrated polyps has been strongly correlated with ADR
About 50 of small polyps are non-adenomatous and these polyps have no malignancy potential especially for small polyps whose cancer risk is extremely low 0-06 The resection of these non-adenomatous polyps may increase medical costs and risks related to post-polypectomy complications bleeding perforation
Real time optical diagnosis by artificial intelligence can improve the cost-benefit and efficiency of colonoscopy as an auxiliary tool in the decision making of which polyps should be resected and which polyps should be recovered for histological characterization However its practical application implies a negative predictive value 90 in optical diagnosis in order to dont have implications in terms of interval CRC and medico-legal issues
CAD EYE Fujifilm Europe Gesellschaft mit beschränkter Haftung Dusseldorf Germany is a fully-automated computer program which allows the detection of colorectal polyps as well as their histological classification using the artificial intelligence technology using deep learning so-called REilI When applied in a high-quality colonoscopy it seems to improve the detection rate of polyps and the ADR in real time during colonoscopy course In fact the detection of difficult lesions remains one of the major challenges in the endoscopy field in last years particularly for flat lesions multiple polyps and polyps located at the image periphery The detection of colorectal polyps is shown by 3 simultaneous identifiers 2 visual and 1 auditory The visual identifiers correspond to a detection box in the area of suspected polyps and a semicircle at the periphery of the image corresponding to the quadrant where the suspect polyps are located The auditory stimulus corresponds to a volume adjustable sound signal emitted when a suspect polyps is detected Regarding the optical characterization of histopathology colo-rectal polyps are classified into 2 types hyperplastic green colour which include hyperplastic and serrated polyps and neoplastic yellow colour for adenomas and adenocarcinomas In addition it allows to perform this characterization in 3 confidence levels and the mapping of the position of the suspected area
This system allows the storage of videos related to both detection and characterization of colorectal polyps one of the recognized quality tools in colonoscopy
The detection mode of colorectal polyps is performed in white light imaging WLI or Linked Colour Imaging LCI while the optical characterization is performed in Blue Light Imaging BLI mode without the need to fix or zoom the image This tool is user-friendly simple intuitive and does not interfere with colonoscopy images
Objectives
Primary objectives
To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE system in real-time optical characterization of colorectal polyps compared to digital chromoendoscopy
To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE system in real-time optical characterization of colorectal polyps by comparison with histopathological analysis
Secondary objectives
To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE system in real-time optical characterization of colorectal polyps in terms of dimension 5 6-9mm and 10mm location and histological type hyperplastic serrated sessile lesion adenoma adenocarcinoma
To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE system in real-time optical characterization of colorectal polyps according to the experience of the endoscopist
Population and methodology
Type of study Prospective observational cohort study
Type of sample The total number of consecutive patients who underwent elective colonoscopy with high quality of bowel preparation at least two points per segment and at least of six points at the total score of Boston Bowel Preparation performed at the Gastroenterology Department of the Centro Hospitalar e Universitário de Coimbra EPE Coimbra Portugal with at least one identified colorectal polyp regardless the indication for its performance
Study design All colonoscopies will be performed by the endoscopist trainee and experienced endoscopist using CAD EYE in detection mode WLI or LCI during colonoscopy retrieval When a suspected polyp is identified by the endoscopist optical characterization is performed by the endoscopist in WLI and BLI modes in a first phase and by the CAD EYE with BLI in a second phase
Methods plan Phase 1 Brief virtual chromoendoscopy training on the characterization of colorectal polyps WLI LCI and BLI
Phase 2 CAD EYE system applied during colonoscopy retrieval
21 CAD EYE system OFF Virtual chromoendoscopy BLI - independently characterization of a suspected polyp in WLI and BLI by the first endoscopist and by the second endoscopist iconographic record 22 CAD EYE system ON Characterization mode BLI Characterization of a suspected polyp by CAD EYE and respectively level of characterization 1 to 3 iconographic record Phase 3 Histopathological evaluation pathologist with gastrointestinal expertise Resection and recovery of a suspected polyp for anatomopathological characterization
Detailed explanation of Methods phases Phase 1 Brief virtual chromoendoscopy training on the characterization of colorectal polyps WLI LCI and BLI Virtual chromoendoscopy training should be performed online through the BASIC e-learning platform blieucategorye-learning This training should be carried out by all participants enrolled in the project trainees and experienced endoscopists before its practical application which will allow skills acquisition on the characterization of virtual chromoendoscopy of colorectal polyps using BLI Additionally a brief review of the Kudo classification of pit pattern of colorectal polyps should be carried out
Phase 2 Evaluation of colorectal polyps in real-time - Optical characterization of colorectal polyps The first approach on optical characterization of an identified polyp consists in the evaluation of the polyp first in WLI mode and then in BLI mode with CAD EYE OFF This evaluation should be systematically performed by two independent endoscopists in the exam room and the evaluation of both should be recorded on a separate record sheet by the endoscopist who is not performing the examination The two endoscopists should preferably but not necessarily be an experienced endoscopist and a trainee from the last few years and the presence of at least one experienced endoscopist is mandatory The independent evaluation is guaranteed by a phased and recorded approach 1st step - The 1st endoscopist endoscopist performing colonoscopy request the polyp evaluation and written record by the 2nd endoscopist the one who is not performing the colonoscopy - blinded evaluation because the 1st endoscopist doesnt verbalize his evaluation 2nd moment - when the 2nd endoscopist signals that he has completed his record the 1st endoscopist verbally explicit his classification which is recorded by the 2nd endoscopist This evaluation should include the histopathological type of polyp hyperplastic adenoma sessile serrated lesion or other type and the level of confidence of the evaluation performed high or low Kudo classification of pit pattern can also be recorded optional
Afterwards optical characterization mode of CAD EYE CAD EYE ON in BLI mode should be activated for the evaluation of CAD EYE optical characterization in hyperplastic or neoplastic polyps as well as the level of characterization graduated from 1 to 3 The evaluation of the CAD EYE should also be recorded by the endoscopist in the exam room who is not performing the colonoscopy on its own record sheet
The iconographic record of evaluated polyps in WLI and BLI modes and the evaluation video using CAD EYE in BLI characterization mode should be done
Phase 3 Histopathological evaluation by pathologist with gastrointestinal expertise After detection and optical characterization of identified colorectal polyps their resection should be performed by the most appropriate technique according to the size and type of polyp cold forceps polypectomy if dimensions 3mm cold snare polypectomy if dimension between 3-10mm and diathermic snare polypectomyendoscopic mucosal resection if lesions 10mm and recovery of colorectal polyp for anatomopathological characterization Each colorectal polyp should be recovered to a separate vial Unrecovered polyps will not be counted for comparative evaluation of optical characterization
Statistical analysis The diagnostic performance of CAD EYE will be evaluated by comparison with the gold standard histological characterization in the optical characterization phase in terms of diagnostic accuracy sensitivity specificity positive predictive value and negative predictive value Sub-analysis can be performed regarding the size location and histological type of polyp as well as the expertise of the endoscopist
Sample size calculation For an alpha risk of 005 and beta risk of 02 for a bilateral test it will be necessary to include 197 colorectal polyps assuming the initial pre-intervention diagnostic ratio is 07 and the final after-intervention ratio is 082
Expected Results It is expected that the new CAD EYE system will have a diagnostic accuracy in the optical characterization of colorectal polyps around 784 comparable to experienced endoscopists 784 vs 796 and superior to less experienced endoscopists 707 vs 79614 Thus the new CAD EYE system will allow optical characterization with high accuracy impacting as a decision making tool for the endoscopist in strategies based on optical diagnosis such as diagnosis and leave behind for diminutive polyps from sigmoid colon and rectum with high degree of confidence in hyperplastic histology and predict resect and discard for diminutive polyps
About 50 of small polyps are non-adenomatous and these polyps have no malignancy potential especially for small polyps whose cancer risk is extremely low 0-06 The resection of these non-adenomatous polyps may increase medical costs and risks related to post-polypectomy complications bleeding perforation
Real time optical diagnosis by artificial intelligence can improve the cost-benefit and efficiency of colonoscopy as an auxiliary tool in the decision making of which polyps should be resected and which polyps should be recovered for histological characterization However its practical application implies a negative predictive value 90 in optical diagnosis in order to dont have implications in terms of interval CRC and medico-legal issues
CAD EYE Fujifilm Europe Gesellschaft mit beschränkter Haftung Dusseldorf Germany is a fully-automated computer program which allows the detection of colorectal polyps as well as their histological classification using the artificial intelligence technology using deep learning so-called REilI When applied in a high-quality colonoscopy it seems to improve the detection rate of polyps and the ADR in real time during colonoscopy course In fact the detection of difficult lesions remains one of the major challenges in the endoscopy field in last years particularly for flat lesions multiple polyps and polyps located at the image periphery The detection of colorectal polyps is shown by 3 simultaneous identifiers 2 visual and 1 auditory The visual identifiers correspond to a detection box in the area of suspected polyps and a semicircle at the periphery of the image corresponding to the quadrant where the suspect polyps are located The auditory stimulus corresponds to a volume adjustable sound signal emitted when a suspect polyps is detected Regarding the optical characterization of histopathology colo-rectal polyps are classified into 2 types hyperplastic green colour which include hyperplastic and serrated polyps and neoplastic yellow colour for adenomas and adenocarcinomas In addition it allows to perform this characterization in 3 confidence levels and the mapping of the position of the suspected area
This system allows the storage of videos related to both detection and characterization of colorectal polyps one of the recognized quality tools in colonoscopy
The detection mode of colorectal polyps is performed in white light imaging WLI or Linked Colour Imaging LCI while the optical characterization is performed in Blue Light Imaging BLI mode without the need to fix or zoom the image This tool is user-friendly simple intuitive and does not interfere with colonoscopy images
Objectives
Primary objectives
To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE system in real-time optical characterization of colorectal polyps compared to digital chromoendoscopy
To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE system in real-time optical characterization of colorectal polyps by comparison with histopathological analysis
Secondary objectives
To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE system in real-time optical characterization of colorectal polyps in terms of dimension 5 6-9mm and 10mm location and histological type hyperplastic serrated sessile lesion adenoma adenocarcinoma
To evaluate the diagnostic accuracy of computer-aided diagnosis using CAD EYE system in real-time optical characterization of colorectal polyps according to the experience of the endoscopist
Population and methodology
Type of study Prospective observational cohort study
Type of sample The total number of consecutive patients who underwent elective colonoscopy with high quality of bowel preparation at least two points per segment and at least of six points at the total score of Boston Bowel Preparation performed at the Gastroenterology Department of the Centro Hospitalar e Universitário de Coimbra EPE Coimbra Portugal with at least one identified colorectal polyp regardless the indication for its performance
Study design All colonoscopies will be performed by the endoscopist trainee and experienced endoscopist using CAD EYE in detection mode WLI or LCI during colonoscopy retrieval When a suspected polyp is identified by the endoscopist optical characterization is performed by the endoscopist in WLI and BLI modes in a first phase and by the CAD EYE with BLI in a second phase
Methods plan Phase 1 Brief virtual chromoendoscopy training on the characterization of colorectal polyps WLI LCI and BLI
Phase 2 CAD EYE system applied during colonoscopy retrieval
21 CAD EYE system OFF Virtual chromoendoscopy BLI - independently characterization of a suspected polyp in WLI and BLI by the first endoscopist and by the second endoscopist iconographic record 22 CAD EYE system ON Characterization mode BLI Characterization of a suspected polyp by CAD EYE and respectively level of characterization 1 to 3 iconographic record Phase 3 Histopathological evaluation pathologist with gastrointestinal expertise Resection and recovery of a suspected polyp for anatomopathological characterization
Detailed explanation of Methods phases Phase 1 Brief virtual chromoendoscopy training on the characterization of colorectal polyps WLI LCI and BLI Virtual chromoendoscopy training should be performed online through the BASIC e-learning platform blieucategorye-learning This training should be carried out by all participants enrolled in the project trainees and experienced endoscopists before its practical application which will allow skills acquisition on the characterization of virtual chromoendoscopy of colorectal polyps using BLI Additionally a brief review of the Kudo classification of pit pattern of colorectal polyps should be carried out
Phase 2 Evaluation of colorectal polyps in real-time - Optical characterization of colorectal polyps The first approach on optical characterization of an identified polyp consists in the evaluation of the polyp first in WLI mode and then in BLI mode with CAD EYE OFF This evaluation should be systematically performed by two independent endoscopists in the exam room and the evaluation of both should be recorded on a separate record sheet by the endoscopist who is not performing the examination The two endoscopists should preferably but not necessarily be an experienced endoscopist and a trainee from the last few years and the presence of at least one experienced endoscopist is mandatory The independent evaluation is guaranteed by a phased and recorded approach 1st step - The 1st endoscopist endoscopist performing colonoscopy request the polyp evaluation and written record by the 2nd endoscopist the one who is not performing the colonoscopy - blinded evaluation because the 1st endoscopist doesnt verbalize his evaluation 2nd moment - when the 2nd endoscopist signals that he has completed his record the 1st endoscopist verbally explicit his classification which is recorded by the 2nd endoscopist This evaluation should include the histopathological type of polyp hyperplastic adenoma sessile serrated lesion or other type and the level of confidence of the evaluation performed high or low Kudo classification of pit pattern can also be recorded optional
Afterwards optical characterization mode of CAD EYE CAD EYE ON in BLI mode should be activated for the evaluation of CAD EYE optical characterization in hyperplastic or neoplastic polyps as well as the level of characterization graduated from 1 to 3 The evaluation of the CAD EYE should also be recorded by the endoscopist in the exam room who is not performing the colonoscopy on its own record sheet
The iconographic record of evaluated polyps in WLI and BLI modes and the evaluation video using CAD EYE in BLI characterization mode should be done
Phase 3 Histopathological evaluation by pathologist with gastrointestinal expertise After detection and optical characterization of identified colorectal polyps their resection should be performed by the most appropriate technique according to the size and type of polyp cold forceps polypectomy if dimensions 3mm cold snare polypectomy if dimension between 3-10mm and diathermic snare polypectomyendoscopic mucosal resection if lesions 10mm and recovery of colorectal polyp for anatomopathological characterization Each colorectal polyp should be recovered to a separate vial Unrecovered polyps will not be counted for comparative evaluation of optical characterization
Statistical analysis The diagnostic performance of CAD EYE will be evaluated by comparison with the gold standard histological characterization in the optical characterization phase in terms of diagnostic accuracy sensitivity specificity positive predictive value and negative predictive value Sub-analysis can be performed regarding the size location and histological type of polyp as well as the expertise of the endoscopist
Sample size calculation For an alpha risk of 005 and beta risk of 02 for a bilateral test it will be necessary to include 197 colorectal polyps assuming the initial pre-intervention diagnostic ratio is 07 and the final after-intervention ratio is 082
Expected Results It is expected that the new CAD EYE system will have a diagnostic accuracy in the optical characterization of colorectal polyps around 784 comparable to experienced endoscopists 784 vs 796 and superior to less experienced endoscopists 707 vs 79614 Thus the new CAD EYE system will allow optical characterization with high accuracy impacting as a decision making tool for the endoscopist in strategies based on optical diagnosis such as diagnosis and leave behind for diminutive polyps from sigmoid colon and rectum with high degree of confidence in hyperplastic histology and predict resect and discard for diminutive polyps
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None