Clinical Trial: Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Brief Summary: The investigators seek to compare the accuracy of the existing colonoscope model to determine the magnitude of the improvement the investigators can expect in polyp discrimination as neoplastic or non-neoplastic.

Detailed Summary: Information will be collected. Images will be taken.
Sponsor: Mayo Clinic

Current Primary Outcome: Accuracy of In Vivo determination of colorectal polyps histopathology [ Time Frame: 1 year ]

Compare accuracy of current colonoscope to improved colonoscope for discrimination of polyps as neoplastic versus non-neoplastic. The accuracies of the two approaches will be compared via logistic regression model with the significance of the difference in the accuracies assessed via generalized estimating equation approach to take account of the possible dependence introduced by inclusion of mulitple polyps per patient.


Original Primary Outcome: Same as current

Current Secondary Outcome: Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes. [ Time Frame: 1 year ]

Estimate the sensitivity and specificity in high definition mode for distinguishing neoplastic from none neoplastic lesions. Sensitivity and specificity will be estimated using the logistic regression approach as above; 95% confidence intervals will be obtained by transforming confidence intervals on the logs odds scale.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: May 16, 2011
Date Started: January 2011
Date Completion:
Last Updated: January 8, 2014
Last Verified: January 2014