Beltway Surgical Center
Indianapolis, Indiana, 46280, United States
NCT Number: NCT01572428
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.
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Notify Me50 year–85 year
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46280, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
Other names: Colonoscopy
Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
Other names: Colonoscopy
Time frame: During the colonoscopy procedure
Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
Time frame: During the colonoscopy procedure
Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).
Time frame: During the colonoscopy procedure
Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon).
Time frame: During the colonoscopy procedure
Total quantity of adenomas found during colonoscopy procedure.
Time frame: During the colonoscopy procedure
Average number of adenomas (located anywhere throughout the colon) found per patient.
Time frame: During the colonoscopy procedure
Patient had to have at least 1 polyp that was an adenoma.
Indiana University
Other
Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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