Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

This study is currently recruiting participants.

Verified April 2012 by Seoul National University Hospital

Sponsor:

Information provided by (Responsible Party):

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01577875

First received: April 10, 2012

Last updated: April 15, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 10, 2012

Last Updated Date

April 15, 2012

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification [ Time Frame: After 1 week ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01577875 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sensitivity of the endoscopic histologic prediction with NBI plus magnification [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value.

Original Secondary Outcome Measures ^ICMJE

Sensitivity and Specificity of the endoscopic histologic prediction with NBI plus magnification [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity, specificity, positive predictive value, negative predictive value.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

Official Title ^ICMJE

A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Intestinal Polyps

Intervention ^ICMJE

Device: NBI with magnification

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.

Other Name: Narrow band image with magnification

Study Arm (s)

No Intervention: control group
histologic prediction only with the narrow band imaging (without magnification)

Intervention: Device: NBI with magnification
No Intervention: test group
histologic prediction with narrow band imaging plus magnification

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

122

Estimated Completion Date

March 2013

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with colorectal polyps which are in need of EMR

Exclusion Criteria:

pregnancy, IBD, colorectal cancer, etc.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kyoung Sup Hong, MD

82 (02)2072-0360

kshong1@empal.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01577875

Other Study ID Numbers ^ICMJE

NBI_Zoom_CVS_01

Has Data Monitoring Committee

Yes

Responsible Party

Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kyoung Sup Hong, MD

SNUH Internal Medicine

Information Provided By

Seoul National University Hospital

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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