Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

November 18, 2014 updated by: Seoul National University Hospital

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

The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with colorectal polyps which are in need of EMR

Exclusion Criteria:

  • pregnancy, IBD, colorectal cancer, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
histologic prediction only with the narrow band imaging (without magnification)
OTHER: test group
histologic prediction with narrow band imaging plus magnification
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 Names:
  • Narrow band image with magnification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification
Time Frame: 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.
After 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the endoscopic histologic prediction with NBI plus magnification
Time Frame: 1 Week
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity.
1 Week
Specificity of the endoscopic histologic prediction with NBI plus magnification
Time Frame: 1 Week
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of specificity.
1 Week
Positive predictive value of the endoscopic histologic prediction with NBI plus magnification
Time Frame: 1 Week
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of positive predictive value.
1 Week
Negative predictive value of the endoscopic histologic prediction with NBI plus magnification
Time Frame: 1 Week
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value.
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Kyoung Sup Hong, MD, SNUH Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (ESTIMATE)

April 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI_Zoom_CVS_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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