Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829447
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2023-03-12
Brief Title:
Combining Artificial Intelligence With Balloon Mucosal Exposure Device for Polyp Detection in Screening Individuals
Sponsor:
Valduce Hospital
Organization:
Valduce Hospital
Study Overview
Official Title:
Impact on Polyp Detection of a Computer Aided Detection System CADEYE Combined With a Balloon Mucosal Exposure Device G-EYE 760R in Individuals Participating in a Organized Colorectal Cancer Screening Program
Status:
COMPLETED
Status Verified Date:
2024-03
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:
COMBAT
Brief Summary:
The present trial is aimed at evaluating whether in individuals scheduled for colonoscopy in the framework of a structured FIT Fecal Immunochemical stool test-based colorectal cancer screening program the combination of an AI artificial intelligence system CADEYE with a mucosal exposure device G-EYE 760R endoscope increases the identification of subjects at high risk to develop colorectal cancer according to recent ESGE-European Society of Gastrointestinal Endoscopy guidelines subjects are labelled as high-risk if harboring at least 1 adenoma 10 mm or with high grade dysplasia or 5 adenomas or any serrated polyp 10 mm or with dysplasia when compared to colonoscopy performed with the support of AI only
Individuals fulfilling inclusion criteria are randomized 11 to two different arms Control arm and Interventional arm see below Randomization is based on a computer-generated randomized block sequence stratified according to age 50-61 vs 62-74 and gender male vs female size of the blocks 10 individuals is not communicated to the investigator Allocation is concealed and kept in a sealed envelope which is opened just before starting colonoscopy
Individuals randomized in the Intervention arm receive colonoscopy examination with G-EYE 760R colonoscopes once the cecum is reached the balloon is inflated and the endoscope is withdrawn with the inflated balloon the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase all polyps identified are removed and sent for histopathology examination
Individuals randomized in the Control arm CADEYE only receive colonoscopy with G-EYE 760R colonoscope but the balloon remains deflated for the entire procedure the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase all polyps identified are removed and sent for histopathology examination
The main outcome measure is the rate of high risk individuals across the two study arms
Individuals fulfilling inclusion criteria are randomized 11 to two different arms Control arm and Interventional arm see below Randomization is based on a computer-generated randomized block sequence stratified according to age 50-61 vs 62-74 and gender male vs female size of the blocks 10 individuals is not communicated to the investigator Allocation is concealed and kept in a sealed envelope which is opened just before starting colonoscopy
Individuals randomized in the Intervention arm receive colonoscopy examination with G-EYE 760R colonoscopes once the cecum is reached the balloon is inflated and the endoscope is withdrawn with the inflated balloon the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase all polyps identified are removed and sent for histopathology examination
Individuals randomized in the Control arm CADEYE only receive colonoscopy with G-EYE 760R colonoscope but the balloon remains deflated for the entire procedure the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase all polyps identified are removed and sent for histopathology examination
The main outcome measure is the rate of high risk individuals across the two study arms
Detailed Description:
The Italian Colorectal Cancer CRC screening program invites the resident population aged 50-74 years for Fecal Immunochemical Test FIT every 2 years Subjects who test positive are referred for colonoscopy Colonoscopy and polypectomy prevent incident cases of colorectal cancer by their detection at an early and curable stage and by identification and removal of colorectal precancerous lesions ie adenomas Taking into account the number and the histological features of polyps identified colonoscopy also allows to stratify individuals according to the risk of developing colorectal cancer over time low-risk vs high-risk subjects thus allowing to plan a balanced risk-based follow-up schedule high-risk individuals are scheduled for a surveillance colonoscopy in 3 years whereas low-risk individuals are scheduled for a further FIT test in five years or for a new colonoscopy in 10 years However colonoscopy is far from being a flawless tool Studies that have measured the incidence of colorectal cancer diagnosed in subjects who have recently undergone colonoscopy with negative results the so-called interval cancers have shown that a significant portion of interval cancers is related to pre-neoplastic or frankly neoplastic colonic lesions missed during the endoscopic procedure
In the last few years it has been shown that in patients undergoing colonoscopy for mixed indications AI-based systems can effectively support the endoscopist by decreasing the adenoma miss rate and by increasing the identification of colonic polyps thus potentially lowering the rate of interval cancer and increasing the rate of individuals scheduled for a short follow-up A recent study demonstrated that AI-assisted colonoscopy is effective also in the framework of a FIT-based organized CRC screening program resulting in an absolute difference of 83 and 023 for adenoma detection rate ADR and for adenomas per colonoscopy APC when compared to standard colonoscopy performed without the assistance of AI Nevertheless tandem studies have shown that despite the use of AI systems the miss rate of colonic adenomas is still about 15-20 In fact AI systems only allow to highlight polyps that are framed by the endoscopist within the screen Therefore the use of computerized AI-based system cannot disregard an accurate retraction technique focused on exploring in an extensive and effective way the space between the folds Several tools mostly consisting of distal attachments or plastic caps aimed at facilitating the evaluation of the space between the folds favoring their smoothing during the endoscope withdrawal have been developed to maximize mucosal exposure Among them the G-EYE system includes a balloon integrated at the distal tip of a standard colonoscope which flattens haustral folds centralizes the colonoscopes optics and reduces bowel slippage during endoscope withdrawal Initial studies showed that G-EYE balloon system when compared with standard colonoscopy increases not only adenoma detection rate but also the detection of advanced flat and sessile serrated adenomaspolyps Recently a new user friendly G-EYE balloon system G-EYE 760R endoscope has been marketed it consists of a standard last-generation colonoscope with a permanently integrated balloon placed at the bending section of the endoscope which can be gradually insufflated on-demand by the endoscopist through a pedal control It can be hypothesized that the combination of AI systems with mucosal exposure devices might further decrease the polyp miss rate by maximizing the detection of adenomas Moreover initial studies based on such a strategy combining AI with mucosal exposure devices yielded encouraging results However the combination of CADEYE with G-EYE 760R endoscopes has not been evaluated so far
The present prospective randomized controlled trial is aimed at evaluating whether in individuals scheduled for colonoscopy in the framework of a structured FIT-based colorectal cancer screening program the combination of an AI system CADEYE with a mucosal exposure device G-EYE 760R endoscope increases the identification of subjects at high risk to develop colorectal cancer when compared to colonoscopy performed with the support of AI only In addition it will be also evaluated whether the use of an AI system combined with a mucosal exposure device increases
the adenoma detection rate ie the rate of individuals with at least one histologically confirmed adenoma
the number of adenomas per colonoscopy ie the number of adenomas detected divided by the number of all colonoscopies performed
the serrated lesions with neoplastic potential sessile serrated lesions-SSA traditional serrated adenomas - TSA detection rate
the detection rate of right colon adenomas
the detection rate on non-polypoid colonic lesions Individuals fulfilling the inclusion criteria are randomized 11 in two arms see below Randomization is based on a computer-generated randomized blocks sequence stratified according to age 50-61 vs 62-74 and gender male vs female size of the blocks 10 individuals is not communicated to the investigator Allocation is concealed and kept in a sealed envelope which is opened just before starting the procedure
Randomization groups
Group A CADEYE only all subjects receive colonoscopy with G-EYE 760R colonoscope but the balloon remains deflated for the entire procedure the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase all polyps identified are removed and sent for histopathology examination
Group B CADEYEG-EYE 760R all individuals receive colonoscopy examination with G-EYE 760R colonoscopes once the cecum is reached the balloon is inflated and the endoscope is withdrawn with the inflated balloon the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase all polyps identified are removed and sent for histopathology examination
For the present study a clinical outcome measure such as the rate of high risk individuals across the two study arms is calculated and compared According to recent European Society of Gastrointestinal Endoscopy ESGE guidelines subjects are labelled as high-risk if harboring at least 1 adenoma 10 mm or with high grade dysplasia or 5 adenomas or any serrated polyp 10 mm or with dysplasia
All endoscopic procedures are performed using the ELUXEOTM 7000 endoscopy platform including videoprocessor ELUXEO TM VP-7000 and light source ELUXEO TM BL-7000 Fujifilm Co Tokyo Japan high-definition 26monitors Barco NV Kortijk Belgium and G-EYE 760R endoscopes Fujifilm Co Tokyo Japan
Bowel preparation is a split regimen of low-volume solution according to local protocol Quality of bowel cleansing is recorded by using the Boston Bowel Preparation Scale Colonoscopies are performed under conscious sedation with carbon dioxide insufflation Intubation time overall withdrawal time intervention time and inspection time during withdrawal are measured using a stopwatch An inspection time of at least 6 minutes 2 minutes in each colonic segment namely right transverse and left colon is mandatory in both study arms The mucosa is carefully inspected and all polyps are classified according to their location size and morphology according to Paris classification The pathologists measure when available is considered the reference standard the endoscopists measure estimation is used in the remaining cases ie piecemeal resection Polyp location is defined as proximal if proximal to the splenic flexure All identified polyps are removed biopsy for non-resectable lesions irrespective of size color or subjective interpretation with the possible exception of very small 1-5 mm hyperplastic-appearing polyps located in the rectum and-according to the judgment of the endoscopists-not clinically significant
All participating endoscopists have credentials for participating in the organized FIT-based screening program more than 300 colonoscopiesyear cecal intubation rate 95 adenoma detection rate25 All endoscopist are familiar with CADEYE features and use this system on a regular basis All participating endoscopists receive a formal training a 20 lecture focused on the use of the G-EYE 760R endoscope All of them performed at least 10 colonoscopies with the G-EYE 760R endoscope to become acquainted with the system before entering the study
All resected or biopsy specimens are fixed in 10 buffered formalin solution sent to pathology in separate jars They are processed and stained for histopathology using standard methods and evaluated by expert pathologists one in each center with credentials to participate in the FIT-based organized screening program pathologists are blinded to the assigned examination mode All lesions are classified according to Vienna classification An advanced adenoma is defined as an adenoma 10 mm andor with villous component 20 andor high-grade dysplasia
In the last few years it has been shown that in patients undergoing colonoscopy for mixed indications AI-based systems can effectively support the endoscopist by decreasing the adenoma miss rate and by increasing the identification of colonic polyps thus potentially lowering the rate of interval cancer and increasing the rate of individuals scheduled for a short follow-up A recent study demonstrated that AI-assisted colonoscopy is effective also in the framework of a FIT-based organized CRC screening program resulting in an absolute difference of 83 and 023 for adenoma detection rate ADR and for adenomas per colonoscopy APC when compared to standard colonoscopy performed without the assistance of AI Nevertheless tandem studies have shown that despite the use of AI systems the miss rate of colonic adenomas is still about 15-20 In fact AI systems only allow to highlight polyps that are framed by the endoscopist within the screen Therefore the use of computerized AI-based system cannot disregard an accurate retraction technique focused on exploring in an extensive and effective way the space between the folds Several tools mostly consisting of distal attachments or plastic caps aimed at facilitating the evaluation of the space between the folds favoring their smoothing during the endoscope withdrawal have been developed to maximize mucosal exposure Among them the G-EYE system includes a balloon integrated at the distal tip of a standard colonoscope which flattens haustral folds centralizes the colonoscopes optics and reduces bowel slippage during endoscope withdrawal Initial studies showed that G-EYE balloon system when compared with standard colonoscopy increases not only adenoma detection rate but also the detection of advanced flat and sessile serrated adenomaspolyps Recently a new user friendly G-EYE balloon system G-EYE 760R endoscope has been marketed it consists of a standard last-generation colonoscope with a permanently integrated balloon placed at the bending section of the endoscope which can be gradually insufflated on-demand by the endoscopist through a pedal control It can be hypothesized that the combination of AI systems with mucosal exposure devices might further decrease the polyp miss rate by maximizing the detection of adenomas Moreover initial studies based on such a strategy combining AI with mucosal exposure devices yielded encouraging results However the combination of CADEYE with G-EYE 760R endoscopes has not been evaluated so far
The present prospective randomized controlled trial is aimed at evaluating whether in individuals scheduled for colonoscopy in the framework of a structured FIT-based colorectal cancer screening program the combination of an AI system CADEYE with a mucosal exposure device G-EYE 760R endoscope increases the identification of subjects at high risk to develop colorectal cancer when compared to colonoscopy performed with the support of AI only In addition it will be also evaluated whether the use of an AI system combined with a mucosal exposure device increases
the adenoma detection rate ie the rate of individuals with at least one histologically confirmed adenoma
the number of adenomas per colonoscopy ie the number of adenomas detected divided by the number of all colonoscopies performed
the serrated lesions with neoplastic potential sessile serrated lesions-SSA traditional serrated adenomas - TSA detection rate
the detection rate of right colon adenomas
the detection rate on non-polypoid colonic lesions Individuals fulfilling the inclusion criteria are randomized 11 in two arms see below Randomization is based on a computer-generated randomized blocks sequence stratified according to age 50-61 vs 62-74 and gender male vs female size of the blocks 10 individuals is not communicated to the investigator Allocation is concealed and kept in a sealed envelope which is opened just before starting the procedure
Randomization groups
Group A CADEYE only all subjects receive colonoscopy with G-EYE 760R colonoscope but the balloon remains deflated for the entire procedure the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase all polyps identified are removed and sent for histopathology examination
Group B CADEYEG-EYE 760R all individuals receive colonoscopy examination with G-EYE 760R colonoscopes once the cecum is reached the balloon is inflated and the endoscope is withdrawn with the inflated balloon the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase all polyps identified are removed and sent for histopathology examination
For the present study a clinical outcome measure such as the rate of high risk individuals across the two study arms is calculated and compared According to recent European Society of Gastrointestinal Endoscopy ESGE guidelines subjects are labelled as high-risk if harboring at least 1 adenoma 10 mm or with high grade dysplasia or 5 adenomas or any serrated polyp 10 mm or with dysplasia
All endoscopic procedures are performed using the ELUXEOTM 7000 endoscopy platform including videoprocessor ELUXEO TM VP-7000 and light source ELUXEO TM BL-7000 Fujifilm Co Tokyo Japan high-definition 26monitors Barco NV Kortijk Belgium and G-EYE 760R endoscopes Fujifilm Co Tokyo Japan
Bowel preparation is a split regimen of low-volume solution according to local protocol Quality of bowel cleansing is recorded by using the Boston Bowel Preparation Scale Colonoscopies are performed under conscious sedation with carbon dioxide insufflation Intubation time overall withdrawal time intervention time and inspection time during withdrawal are measured using a stopwatch An inspection time of at least 6 minutes 2 minutes in each colonic segment namely right transverse and left colon is mandatory in both study arms The mucosa is carefully inspected and all polyps are classified according to their location size and morphology according to Paris classification The pathologists measure when available is considered the reference standard the endoscopists measure estimation is used in the remaining cases ie piecemeal resection Polyp location is defined as proximal if proximal to the splenic flexure All identified polyps are removed biopsy for non-resectable lesions irrespective of size color or subjective interpretation with the possible exception of very small 1-5 mm hyperplastic-appearing polyps located in the rectum and-according to the judgment of the endoscopists-not clinically significant
All participating endoscopists have credentials for participating in the organized FIT-based screening program more than 300 colonoscopiesyear cecal intubation rate 95 adenoma detection rate25 All endoscopist are familiar with CADEYE features and use this system on a regular basis All participating endoscopists receive a formal training a 20 lecture focused on the use of the G-EYE 760R endoscope All of them performed at least 10 colonoscopies with the G-EYE 760R endoscope to become acquainted with the system before entering the study
All resected or biopsy specimens are fixed in 10 buffered formalin solution sent to pathology in separate jars They are processed and stained for histopathology using standard methods and evaluated by expert pathologists one in each center with credentials to participate in the FIT-based organized screening program pathologists are blinded to the assigned examination mode All lesions are classified according to Vienna classification An advanced adenoma is defined as an adenoma 10 mm andor with villous component 20 andor high-grade dysplasia
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