colorectal adenoma
Conditions
Interventions
Back-to-back colonoscopy with two different colonoscopy systems.
Sponsors
Olympus
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age greater than or equal to 18 years • High risk for colorectal cancer: FOBT positive, personal or familial (first degree relatives) history of colorectal cancer or colorectal adenoma, patients with symptoms suggestive of colorectal neoplasm: rectal bleeding, recent change in frequency and consistency of stools. • Status 1 and 2 of the ASA classification (see Appendix I) • Signed informed consent
Exclusion criteria
Exclusion criteria: • Mental or physical condition that can adversely affect the preparation or conduct of the examination or which precludes compliance with the study and / or device instructions. • Inability to undergo bowel cleansing for colonoscopy. • Prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or cholecystectomy). • Known or suspicion of inflammatory bowel disease. • Colonic diverticulosis complication within 3 months prior inclusion. • Very high risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease (Familial Adenomatous Polyposis (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC)). • Coagulation abnormalities or taking drugs affecting coagulation. • Life threatening conditions • Status > 2 of the ASA classification (see Appendix I). • Renal insufficiency or any contraindication or medication contraindicating the administration of bowel cleansing. • Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception. • Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint: Sensitivity of HD2/NBI2 colonoscopy for the detection of colorectal adenomas in comparison to nonHD-nonNBI colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints: • Sensitivity of HD2/NBI2 colonoscopy for the detection of advanced colorectal adenomas in comparison to nonHD-nonNBI colonoscopy. • Sensitivity of HD2/NBI2 colonoscopy for the detection of colorectal adenomas larger than 10mm in diameter in comparison to nonHD - nonNBI colonoscopy. • Gross appearance (Paris Classification) of adenomas identified in the group HD2/NBI2 compared to the nonHD-nonNBI group. • Location of adenomas identified in the group HD2/NBI2 compared to the white light group. • Sensitivity of NBI colonoscopy for the detection of hyperplastic polyps in comparison to nonHD-nonNBI colonoscopy. • Adenoma miss rate using HD2/NBI2 in comparison to nonHD-nonNBI imaging. • Prevalence of patients with at least one adenoma using HD2/NBI2 in comparison to nonHD-nonNBI colonoscopy. • Evaluation of the sensitivity of NICE criteria using HD2/NBI2 *near focus* to predict the nature of adenomatous colorectal polyps | — |
Countries
Netherlands
Outcome results
None listed