Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon

Study Overview
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Brief Summary
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This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.

Detailed Description
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This is a randomized controlled trial comparing the use of Narrow-Band Imaging (illumination of the colon in blue light)versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Narrow-Band Imaging has anecdotally been used to highlight the appearance of these lesions. This study will test whether Narrow-Band Imaging increases the detection of serrated lesions in a randomized controlled trial.

Official Title
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Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: Inspection with Narrow-Band Imaging(NBI)
* Procedure: Standard White Light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50-85 Intact colon and rectum American Society of Anesthesiology risk class 1, 2 or 3 Exclusion Criteria: No prior surgical resection of colon or rectum

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narrow-Band Imaging (NBI)<br>Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care) | Procedure: Inspection with Narrow-Band Imaging(NBI)<br>* Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.<br>* Other names: Colonoscopy;|
| Active Comparator: Standard White Light<br>Inspection with Standard White Light versus Narrow-Band Imaging(NBI) | Procedure: Inspection with Narrow-Band Imaging(NBI)<br>* Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.<br>* Other names: Colonoscopy;Procedure: Standard White Light<br>* Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.<br>* Other names: Colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Serrated Lesions Proximal to the Sigmoid Colon | Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy. | During the colonoscopy procedure | 
| Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient | Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon). | During the colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon | Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon). | During the colonoscopy procedure | 
| Total Number of Conventional Adenomas in Entire Colon | Total quantity of adenomas found during colonoscopy procedure. | During the colonoscopy procedure | 
| Number of Conventional Adenomas Per Patient in Entire Colon | Average number of adenomas (located anywhere throughout the colon) found per patient. | During the colonoscopy procedure | 
| Patients With 1 or More Conventional Adenomas | Patient had to have at least 1 polyp that was an adenoma. | During the colonoscopy procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal Colon Cancer, Serrated Colon Lesions, Narrow Band Imaging