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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572428
• Other study ID #: 1012-17
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: July 7, 2014

Study information

• Verified date: June 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 898
• Est. completion date: July 7, 2014
• Est. primary completion date: July 7, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Beltway Surgical Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Olympus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Serrated Lesions Proximal to the Sigmoid Colon	Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.	During the colonoscopy procedure
Primary	Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient	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	Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon	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
Secondary	Total Number of Conventional Adenomas in Entire Colon	Total quantity of adenomas found during colonoscopy procedure.	During the colonoscopy procedure
Secondary	Number of Conventional Adenomas Per Patient in Entire Colon	Average number of adenomas (located anywhere throughout the colon) found per patient.	During the colonoscopy procedure
Secondary	Patients With 1 or More Conventional Adenomas	Patient had to have at least 1 polyp that was an adenoma.	During the colonoscopy procedure