Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study
- Conditions
- Colorectal CancerColorectal NeoplasmsColonic Polyps
- Interventions
- Device: Olympus Colonoscope CFHQ190AL
- Registration Number
- NCT01310699
- Lead Sponsor
- VA Palo Alto Health Care System
- Brief Summary
We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.
- Detailed Description
Interval colorectal cancers diagnosed within a three year period following a clearing colonoscopy have been reported at a rate of 1 cancer/1000 person years.The majority of these cancers are likely a consequence of a missed neoplastic lesion during routine colonoscopy. Recent tandem colonoscopy studies have shown no significant difference in adenoma miss or detection rates using narrow band imaging as compared to colonoscopy using white light. However, higher detection of flat neoplastic lesions using NBI was shown in a meta-analysis and should be furthered studied, especially considering that they are thought to be a strong contributor to a false negative colonoscopy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
- Adult patients referred for routine colonoscopy are eligible
- Known Inflammatory bowel disease
- Referred for endoscopic evaluation and removal of colorectal lesion
- Personal or family history of polyposis or non-polyposis syndrome
- Presentation for emergency endoscopy
- Inability to remove polyp due to coagulopathy or thrombocytopenia
- Inability to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Definition NBI Colonoscopy Olympus Colonoscope CFHQ190AL Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging. High Definition White Light Colonoscopy Olympus Colonoscope CFHQ190AL Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
- Primary Outcome Measures
Name Time Method Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm One week (time of procedure plus time for pathology of polyp to be analyzed by histology) Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.
- Secondary Outcome Measures
Name Time Method Percentage of Nonpolypoid (Flat) Missed Lesions One week (time of procedure plus time for pathology of polyp to be analyzed by histology) Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.
Percentage of Missed Lesions on Index Colonoscopy. One week (time of procedure plus time for pathology of polyp to be analyzed by histology) Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.
Trial Locations
- Locations (3)
Veterans Affairs Palo Alto
🇺🇸Palo Alto, California, United States
Veterans Affairs Kansas City
🇺🇸Kansas City, Missouri, United States
Veterans Affairs San Francisco
🇺🇸San Francisco, California, United States