We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01572428
First Posted: April 6, 2012
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Olympus
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University
  Purpose
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.

Condition Intervention
Colon Cancer Procedure: Inspection with Narrow-Band Imaging(NBI) Procedure: Standard White Light

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon

Resource links provided by NLM:


Further study details as provided by Douglas K. Rex, Indiana University:

Primary Outcome Measures:
  • Number of Proximal Serrated lesions [ Time Frame: 1 year ]
    Quantity of serrated lesions found in the proximal colon during colonoscopy.


Estimated Enrollment: 950
Study Start Date: April 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Colonoscopy

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572428


Locations
United States, Indiana
Beltway Surgical Center
Indianapolis, Indiana, United States, 46280
Sponsors and Collaborators
Indiana University
Olympus
Investigators
Principal Investigator: Douglas K Rex, MD Indiana University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas K. Rex, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01572428     History of Changes
Other Study ID Numbers: 1012-17
First Submitted: July 11, 2011
First Posted: April 6, 2012
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by Douglas K. Rex, Indiana University:
Proximal Colon Cancer
Serrated Colon Lesions
Narrow Band Imaging

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases