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Completed

NCT Number: NCT01577875

Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

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

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Key information

Conditions

Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUH

Jongno-gu, Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with colorectal polyps which are in need of EMR

Exclusion criteria

  • pregnancy, IBD, colorectal cancer, etc.

Treatment and study plan

NBI with magnification

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 16, 2012
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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