Patients who receive colonoscopy for colorectal cancer screening
Conditions
Interventions
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
Sponsors
Saito Yutaka
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1) Individuals with poorly controlled complications (including unstable angina, post-acute myocardial infarction, heart failure, chronic respiratory disease, bleeding tendency) that make it difficult to safely perform colonoscopy. 2) When pathological diagnosis of colorectal lesions is not possible due to reasons such as being on antithrombotic medication and being unable to withdraw the medication 3) Clinically suspicious symptoms of CRC, such as bloody stools or abdominal pain 4) History of CRC treatment 5) History of colorectal surgery involving bowel resection of the colon or rectum (history of surgery not involving bowel resection of the colon or rectum, such as appendectomy for appendicitis, is acceptable) 6) Family history of hereditary CRC 7) Have or have had inflammatory bowel disease 8) Colorectal polyposis 9) Have had a colonoscopy within 5 years before the date of registration 10) Other cases deemed inappropriate by the doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenoma detection rate (ADR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Hong Kong, Japan, Singapore, South Korea, Taiwan, Thailand
Contacts
Public ContactMasau Sekiguchi
National Cancer Center Hospital, Japan
Outcome results
None listed