Clinical trial of colonoscopy using computer-aided detection systems in colorectal cancer screening

INTERVENTION: For enrollment, the standard test group and the test group are randomly assigned by the allocation system. In the test methods, such CADe devices as EndoBRAIN‐EYE (Olympus, Cybernet Systems), ENDO‐AID (Olympus), WISE VISION (NEC), CAD EYE (FUJIFILM), which have been approved under the regulations of each country are used. The colonoscopy procedure is similar to the standard examination method, except that CADe assists endoscopists in detecting lesions during colonoscopy. CADe is activated during colonoscopy to alert candidates for polyps, cancer, and other lesions in real time. Different countries and regions have different regulatory approvals for different models. The standard examination method is a conventional colonoscopy without CADe. CONDITION: Patients who receive colonoscopy for colorectal cancer screening PRIMARY OUTCOME: Adenoma detection rate (ADR) SECONDARY OUTCOME: 1) Adenomas per colonoscopy (APC); 2) Detection rate and number of advanced adenomas ; 3) Detection rate and number of colorectal neoplastic lesions other than adenomas, such as colorectal cancer (CRC) and colorectal serrated lesions; 4) Detection rate and number of flat and depressed tumors; 5) Colonoscopy examination time (time for scope insertion (from the anus to the cecum) and time for scope withdrawal from the cecum to the anus); 6) Incidence of adverse events; 7) Resection rate and number of non‐neoplastic polyps in the large intestine; 8) Proprotion of sedative usage INCLUSION CRITERIA: 1) Individuals who are scheduled to undergo total colonoscopy for either reason a) or b). a) Primary screening colonoscopy for CRC screening b) Further colonoscopy due to positive fecal immunochemical test (FIT) upon CRC screening 2) Age at entry is between 50 and 79 years. 3) ECOG Performance status is 0 or 1. 4) Written consent to participate in the study has been obtained.