Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

Not Applicable

Completed

• Conditions: Intestinal Polyps
• Interventions: Device: NBI with magnification

• Registration Number: NCT01577875
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-04
• Study Start: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-16
• Primary Completion: 2012-08
• Study Completion: 2013-03
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Subjects with colorectal polyps which are in need of EMR

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Exclusion Criteria

• pregnancy, IBD, colorectal cancer, etc.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	NBI with magnification	histologic prediction with narrow band imaging plus magnification

Primary Outcome Measures

Name	Time	Method
Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification	After 1 week	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

Name	Time	Method
Specificity of the endoscopic histologic prediction with NBI plus magnification	1 Week	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	1 Week	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	1 Week	Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value.
Sensitivity of the endoscopic histologic prediction with NBI plus magnification	1 Week	Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity.

Trial Locations

Locations (1)

SNUH; 🇰🇷 Jongno-gu, Seoul, Korea, Republic of