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

Not Applicable
Completed
Conditions
Colon Cancer
Interventions
Procedure: Inspection with Narrow-Band Imaging(NBI)
Procedure: Standard White Light
Registration Number
NCT01572428
Lead Sponsor
Indiana University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
898
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard White LightInspection with Narrow-Band Imaging(NBI)Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Narrow-Band Imaging (NBI)Inspection with Narrow-Band Imaging(NBI)Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Standard White LightStandard White LightInspection with Standard White Light versus Narrow-Band Imaging(NBI)
Primary Outcome Measures
NameTimeMethod
Total Number of Serrated Lesions Proximal to the Sigmoid ColonDuring the colonoscopy procedure

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

Number of Serrated Lesions Proximal to the Sigmoid Colon Per PatientDuring 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).

Secondary Outcome Measures
NameTimeMethod
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid ColonDuring 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).

Total Number of Conventional Adenomas in Entire ColonDuring the colonoscopy procedure

Total quantity of adenomas found during colonoscopy procedure.

Number of Conventional Adenomas Per Patient in Entire ColonDuring the colonoscopy procedure

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

Patients With 1 or More Conventional AdenomasDuring the colonoscopy procedure

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

Trial Locations

Locations (1)

Beltway Surgical Center

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Indianapolis, Indiana, United States

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