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

Indiana University

Status: Completed

Conditions: Colon Cancer

Treatments: Procedure: Standard White Light; Procedure: Inspection with Narrow-Band Imaging(NBI)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01572428

1012-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 898 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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898 participants in 2 patient groups

Narrow-Band Imaging (NBI)

Active Comparator group

Description:

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

Treatment:

Procedure: Inspection with Narrow-Band Imaging(NBI)

Standard White Light

Active Comparator group

Description:

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

Treatment:

Procedure: Inspection with Narrow-Band Imaging(NBI)

Procedure: Standard White Light