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

June 27, 2019 updated by: Douglas K. Rex, Indiana University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

898

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Beltway Surgical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Narrow-Band Imaging (NBI)
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Procedure: 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.
Other Names:
  • Colonoscopy
ACTIVE_COMPARATOR: Standard White Light
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Procedure: 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.
Other Names:
  • Colonoscopy
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.
Other Names:
  • Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Time Frame: During the colonoscopy procedure
Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
During the colonoscopy procedure
Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient
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).
During the colonoscopy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid 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).
During the colonoscopy procedure
Total Number of Conventional Adenomas in Entire Colon
Time Frame: During the colonoscopy procedure
Total quantity of adenomas found during colonoscopy procedure.
During the colonoscopy procedure
Number of Conventional Adenomas Per Patient in Entire Colon
Time Frame: During the colonoscopy procedure
Average number of adenomas (located anywhere throughout the colon) found per patient.
During the colonoscopy procedure
Patients With 1 or More Conventional Adenomas
Time Frame: During the colonoscopy procedure
Patient had to have at least 1 polyp that was an adenoma.
During the colonoscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Olympus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

July 7, 2014

Study Completion (ACTUAL)

July 7, 2014

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1012-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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