Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study

Conditions
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Colorectal Neoplasms, Colonic Polyps, Colorectal Cancer

Intervention / Treatment
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* Device: Olympus Colonoscope CFHQ190AL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients referred for routine colonoscopy are eligible Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Definition NBI Colonoscopy<br>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. | Device: Olympus Colonoscope CFHQ190AL<br>* Technically improved colonoscope with close focus high definition narrow band imaging.<br>|
| Placebo Comparator: High Definition White Light Colonoscopy<br>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. | Device: Olympus Colonoscope CFHQ190AL<br>* Technically improved colonoscope with close focus high definition narrow band imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm | Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy. | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Missed Lesions on Index Colonoscopy. | 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. | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) | 
| Percentage of Nonpolypoid (Flat) Missed Lesions | 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. | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Diagnostic imaging, Colorectal Neoplasm, Tandem Colonoscopy, Flat Polyp, Nonpolypoid, Flat and Depressed Lesions, Primary Prevention, Endoscopy