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

NCT ID: NCT01572428

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 898 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-07-07

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Narrow-Band Imaging (NBI)

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

Group Type: ACTIVE_COMPARATOR

Inspection with Narrow-Band Imaging(NBI)

Intervention Type: PROCEDURE

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

Standard White Light

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

Group Type: ACTIVE_COMPARATOR

Inspection with Narrow-Band Imaging(NBI)

Intervention Type: PROCEDURE

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

Standard White Light

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Colonoscopy; Colonoscopy

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Olympus

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Douglas K. Rex

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas K Rex, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Beltway Surgical Center

Indianapolis, Indiana, United States

Countries

United States

References

Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.

Reference Type: DERIVED

PMID: 25952085 (View on PubMed)

Other Identifiers

1012-17

Identifier Type: -

Identifier Source: org_study_id