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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01577875

Enrollment

122

Registered

2012-04-16

Start date

2012-04-30

Completion date

2013-03-31

Last updated

2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal 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.

Interventions

DEVICENBI 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects with colorectal polyps which are in need of EMR

Exclusion criteria

* pregnancy, IBD, colorectal cancer, etc.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026