Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy
A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps
1 other identifier
interventional
122
1 country
1
Brief Summary
The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 10, 2012
CompletedFirst Posted
Study publicly available on registry
April 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedNovember 20, 2014
April 1, 2012
4 months
April 10, 2012
November 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
After 1 week
Secondary Outcomes (4)
Sensitivity of the endoscopic histologic prediction with NBI plus magnification
1 Week
Specificity of the endoscopic histologic prediction with NBI plus magnification
1 Week
Positive predictive value of the endoscopic histologic prediction with NBI plus magnification
1 Week
Negative predictive value of the endoscopic histologic prediction with NBI plus magnification
1 Week
Study Arms (2)
control group
NO INTERVENTIONhistologic prediction only with the narrow band imaging (without magnification)
test group
OTHERhistologic prediction with narrow band imaging plus magnification
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subjects with colorectal polyps which are in need of EMR
You may not qualify if:
- pregnancy, IBD, colorectal cancer, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNUH
Jongno-gu, Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyoung Sup Hong, MD
SNUH Internal Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2012
First Posted
April 16, 2012
Study Start
April 1, 2012
Primary Completion
August 1, 2012
Study Completion
March 1, 2013
Last Updated
November 20, 2014
Record last verified: 2012-04