Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
Primary Purpose
Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspection with Narrow-Band Imaging(NBI)
Standard White Light
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Cancer focused on measuring Proximal Colon Cancer, Serrated Colon Lesions, Narrow Band Imaging
Eligibility 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
Sites / Locations
- Beltway Surgical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Narrow-Band Imaging (NBI)
Standard White Light
Arm Description
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Outcomes
Primary Outcome Measures
Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
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).
Secondary Outcome Measures
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).
Total Number of Conventional Adenomas in Entire Colon
Total quantity of adenomas found during colonoscopy procedure.
Number of Conventional Adenomas Per Patient in Entire Colon
Average number of adenomas (located anywhere throughout the colon) found per patient.
Patients With 1 or More Conventional Adenomas
Patient had to have at least 1 polyp that was an adenoma.
Full Information
NCT ID
NCT01572428
First Posted
July 11, 2011
Last Updated
June 27, 2019
Sponsor
Indiana University
Collaborators
Olympus
1. Study Identification
Unique Protocol Identification Number
NCT01572428
Brief Title
Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 7, 2014 (Actual)
Study Completion Date
July 7, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Olympus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Proximal Colon Cancer, Serrated Colon Lesions, Narrow Band Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
898 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Narrow-Band Imaging (NBI)
Arm Type
Active Comparator
Arm Description
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Arm Title
Standard White Light
Arm Type
Active Comparator
Arm Description
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Intervention Type
Procedure
Intervention Name(s)
Inspection with Narrow-Band Imaging(NBI)
Other Intervention Name(s)
Colonoscopy
Intervention Description
Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
Intervention Type
Procedure
Intervention Name(s)
Standard White Light
Other Intervention Name(s)
Colonoscopy
Intervention Description
Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
Primary Outcome Measure Information:
Title
Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Description
Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
Time Frame
During the colonoscopy procedure
Title
Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient
Description
Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).
Time Frame
During the colonoscopy procedure
Secondary Outcome Measure Information:
Title
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon
Description
Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon).
Time Frame
During the colonoscopy procedure
Title
Total Number of Conventional Adenomas in Entire Colon
Description
Total quantity of adenomas found during colonoscopy procedure.
Time Frame
During the colonoscopy procedure
Title
Number of Conventional Adenomas Per Patient in Entire Colon
Description
Average number of adenomas (located anywhere throughout the colon) found per patient.
Time Frame
During the colonoscopy procedure
Title
Patients With 1 or More Conventional Adenomas
Description
Patient had to have at least 1 polyp that was an adenoma.
Time Frame
During the colonoscopy procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K Rex, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beltway Surgical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25952085
Citation
Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
Results Reference
derived
Learn more about this trial
Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
We'll reach out to this number within 24 hrs