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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Indiana University
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01572428
First received: July 11, 2011
Last updated: April 29, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Indiana University:

Primary Outcome Measures:
  • Number of Proximal Serrated lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quantity of serrated lesions found in the proximal colon during colonoscopy.


Estimated Enrollment: 950
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572428

Contacts
Contact: Beverly A Flamme, AS 317-948-8393 bflamme@iupui.edu

Locations
United States, Indiana
Beltway Surgical Center Recruiting
Indianapolis, Indiana, United States
Contact: Beverly A Flamme, AS    317-948-8393    bflamme@iupui.edu   
Principal Investigator: Douglas K. Rex, MD         
Sub-Investigator: Beverly A Flamme, AS         
Sub-Investigator: Amanda Semla         
Sub-Investigator: Elizabeth Rohn         
Sub-Investigator: Ryan Clodfelter, BS         
Sub-Investigator: Farrah Rahmani, BS         
Sponsors and Collaborators
Indiana University
Olympus
Investigators
Principal Investigator: Douglas K Rex, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01572428     History of Changes
Other Study ID Numbers: 1012-17
Study First Received: July 11, 2011
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 14, 2014