Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

Seoul National University Hospital122 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

122

Conditions

Intestinal Polyps

Interventions

NBI with magnificationDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with colorectal polyps which are in need of EMR Exclusion Criteria: * pregnancy, IBD, colorectal cancer, etc.

Locations (1)

SNUH

Jongno-gu, Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: After 1 week

Secondary Outcomes

Sensitivity of the endoscopic histologic prediction with NBI plus magnification

Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity.

Time frame: 1 Week

Specificity of the endoscopic histologic prediction with NBI plus magnification

Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of specificity.

Time frame: 1 Week

Positive predictive value of the endoscopic histologic prediction with NBI plus magnification

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

Time frame: 1 Week

Negative predictive value of the endoscopic histologic prediction with NBI plus magnification

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

Time frame: 1 Week

Data from ClinicalTrials.gov

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