Back to resultsComparison of Narrow Band Imaging With or Without Magnifying Colonoscopy
Primary Purpose
Intestinal Polyps
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NBI with magnification
Sponsored by
About this trial
This is an interventional diagnostic trial for Intestinal Polyps
Eligibility Criteria
Inclusion Criteria:
- Subjects with colorectal polyps which are in need of EMR
Exclusion Criteria:
- pregnancy, IBD, colorectal cancer, etc.
Sites / Locations
- SNUH
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
control group
test group
Arm Description
histologic prediction only with the narrow band imaging (without magnification)
histologic prediction with narrow band imaging plus magnification
Outcomes
Primary Outcome Measures
Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification
After radomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. After 1 week, confirmed pathologic diagnosis and predicted histologic diagnosis based on endoscopic observation are compared and its accuracy is evaluated.
Secondary Outcome Measures
Sensitivity of the endoscopic histologic prediction with NBI plus magnification
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity.
Specificity of the endoscopic histologic prediction with NBI plus magnification
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of specificity.
Positive predictive value of the endoscopic histologic prediction with NBI plus magnification
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of positive predictive value.
Negative predictive value of the endoscopic histologic prediction with NBI plus magnification
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value.
Full Information
NCT ID
NCT01577875
First Posted
April 10, 2012
Last Updated
November 18, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01577875
Brief Title
Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy
Official Title
A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.
Detailed Description
The accuracy of histologic prediction for the colorectal polyps with the use of narrow band imaging is evaluated between the test group with magnifying colonoscopy and the control group without magnifying colonoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Polyps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
histologic prediction only with the narrow band imaging (without magnification)
Arm Title
test group
Arm Type
Other
Arm Description
histologic prediction with narrow band imaging plus magnification
Intervention Type
Device
Intervention Name(s)
NBI with magnification
Other Intervention Name(s)
Narrow band image with magnification
Intervention Description
After randomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. Two groups will be compared with each other.
Primary Outcome Measure Information:
Title
Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification
Description
After radomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. After 1 week, confirmed pathologic diagnosis and predicted histologic diagnosis based on endoscopic observation are compared and its accuracy is evaluated.
Time Frame
After 1 week
Secondary Outcome Measure Information:
Title
Sensitivity of the endoscopic histologic prediction with NBI plus magnification
Description
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity.
Time Frame
1 Week
Title
Specificity of the endoscopic histologic prediction with NBI plus magnification
Description
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of specificity.
Time Frame
1 Week
Title
Positive predictive value of the endoscopic histologic prediction with NBI plus magnification
Description
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of positive predictive value.
Time Frame
1 Week
Title
Negative predictive value of the endoscopic histologic prediction with NBI plus magnification
Description
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value.
Time Frame
1 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with colorectal polyps which are in need of EMR
Exclusion Criteria:
pregnancy, IBD, colorectal cancer, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoung Sup Hong, MD
Organizational Affiliation
SNUH Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNUH
City
Jongno-gu
State/Province
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy
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