Colonoscopy Clinical Trial
Official title:
The Impact of Narrow Band Imaging in Screening Colonoscopy: a Randomized Controlled Trial.
NCT number | NCT00908648 |
Other study ID # | NBI-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2007 |
Est. completion date | April 2008 |
Verified date | March 2021 |
Source | Valduce Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.
Status | Completed |
Enrollment | 206 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 69 Years |
Eligibility | Inclusion Criteria: - 50-69 year-old asymptomatic subjects at average-risk of CRC - positive FOBT participating in a national mass-screening program and referred for colonoscopy Exclusion Criteria: - ongoing anticoagulation therapy - inadequate bowel cleansing - incomplete colonoscopy - refusing to participate |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Valduce Hospital |
Chiu HM, Chang CY, Chen CC, Lee YC, Wu MS, Lin JT, Shun CT, Wang HP. A prospective comparative study of narrow-band imaging, chromoendoscopy, and conventional colonoscopy in the diagnosis of colorectal neoplasia. Gut. 2007 Mar;56(3):373-9. Epub 2006 Sep 27. — View Citation
Machida H, Sano Y, Hamamoto Y, Muto M, Kozu T, Tajiri H, Yoshida S. Narrow-band imaging in the diagnosis of colorectal mucosal lesions: a pilot study. Endoscopy. 2004 Dec;36(12):1094-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma Detection | Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization | duration of colonoscopy procedure | |
Secondary | Detection of Flat and/or Depressed Adenomas | number of patients with at least 1 flat and/or depressed adenoma | duration of colonoscopy procedure |
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