Clinical Trial: Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Sensitivity and 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 sensitivity, specificity, positive predictive value, negative predictive value.


Information By: Seoul National University Hospital

Dates:
Date Received: April 10, 2012
Date Started: April 2012
Date Completion:
Last Updated: November 18, 2014
Last Verified: April 2012