The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.
Male and female patients aged 40-80 years scheduled for average-risk screening colonoscopy, post-polypectomy surveillance, diagnosis for gastrointestinal symptoms (including unexplained iron deficiency anemia and clinically significant diarrhea of unexplained origin), or referred for colonoscopy owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result.
familial adenomatous polyposis and hereditary non-polyposis CRC syndrome
personal history of serrated polyposis syndrome
personal history of CRC
history of inflammatory bowel disease
Parallel
Water exchange with AI-assisted detection
DeviceThe study employs standard high-definition colonoscopy video processors with integrated CADe system (CAD-EYE, EW10-EC02, Fujifilm) The ELUXEO 7000 system (Fujifilm) will be used in this study. During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patient in the left lateral position. Consistent techniques, ensuring adequate luminal distention and comprehensive fold examination, will be used. The CADe device will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp. All participating endoscopists possess experience and expertise in CADe systems, ensuring readiness before study initiation.
Water exchange with AI-assisted detection and LCI
DeviceThe study employs high-definition colonoscopy video processors with integrated CADe (CAD-EYE, EW10-EC02, Fujifilm) and LCI systems (Fujifilm).The ELUXEO 7000 system will be used . During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patient in the left lateral position. Consistent techniques, ensuring adequate luminal distention and comprehensive fold examination, will be used. The CADe and LCI devices will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp. All participating endoscopists possess experience and expertise in CADe and LCI systems, ensuring readiness before study initiation.
Clinically significant serrated lesion (CSSL) detection rate
Percentage of patients who have 1 or more histologically confirmed CSSLs, including sessile serrated lesions, traditional serrated adenomas, hyperplastic polyps measuring ≥10 mm anywhere in the colon, or hyperplastic polyps measuring 6-9 mm in the proximal colon (cecum to splenic flexure).
Sessile serrated lesion (SSL) detection rate
Percentage of patients who have 1 or more histologically confirmed SSL with or without dysplasia.
Proximal serrated lesion detection rate
Percentage of patients who have 1 or more histologically confirmed proximal serrated lesions, including sessile serrated lesion, translational serrated adenoma, and hyperplastic polyp. The proximal colon includes the cecum, ascending colon, hepatic flexure, transverse colon, and splenic flexure.
High-risk neoplasm detection rate
Percentage of patients who have 1 or more histologically confirmed advanced adenoma, or ≥5 low-risk adenomas (defined as 1 to 2 tubular adenomas \<10 mm with low-grade dysplasia), or any serrated lesions ≥10 mm or with dysplasia. Advanced adenomas are defined as those adenomas meeting at least one of the following criteria: (1) size ≥10 mm, (2) presence of 25% villous components, and (3) high-grade dysplasia.
Adenoma detection rate
Percentage of patients who have 1 or more histologically confirmed conventional adenomas.
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Evergreen General Hospital, Taiwan
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
King Chulalongkorn Memorial Hospital
Collaborator
Valduce Hospital
Collaborator