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Cola

Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)

Inspection with Standard White Light versus Narrow-Band Imaging(NBI)

Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.

Inspection with Narrow-Band Imaging(NBI)

Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.

Standard White Light

Douglas K Rex, MD

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.

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.

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

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

Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.

Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse 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).

Total quantity of adenomas found during colonoscopy procedure.

Average number of adenomas (located anywhere throughout the colon) found per patient.

Patient had to have at least 1 polyp that was an adenoma.

Olympus

Indiana University

Professor

Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)

Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.

Narrow-Band Imaging (NBI)

Inspection with Standard White Light versus Narrow-Band Imaging(NBI)

Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.

Total

Age, Continuous

Sex: Female, Male

White

Black or African American

Other

Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

Current

Past

Never

Tobacco use

ASA 1 -- a normal healthy patient ASA 2 -- a patient with mild systemic disease ASA 3 -- a patient with severe systemic disease

ASA risk class

Screening

Surveillance

Indication

Time from end of colon prep to procedure start

Endoscopists weren't blinded to the type of light being used during withdrawal, which is a limitation of all detection studies. Number of SSPs were not specifically an endpoint of the study, but rather the entire serrated class of polyps.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon	NCT01572428	Colon Cancer	Inspection with... Standard White ...	50 Years - 85 Years	Indiana University
Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon	NCT01572428	Colon Cancer	Inspection with... Standard White ...	50 Years - 85 Years	Indiana University

Spots Global Cancer Trial Database for proximal colon cancer