Skip to main content
OpenTrials
Completed

NCT Number: NCT01572428

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beltway Surgical Center

Indianapolis, Indiana, 46280, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspection with Narrow-Band Imaging(NBI)

Procedure

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

Other names: Colonoscopy

Standard White Light

Procedure

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

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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).

  2. Total Number of Conventional Adenomas in Entire Colon

    Time frame: During the colonoscopy procedure

    Total quantity of adenomas found during colonoscopy procedure.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Olympus

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 6, 2012
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.