Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Completed

• Conditions: Colon Polyps

• Registration Number: NCT01354873
• Lead Sponsor: Mayo Clinic

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 Description

Information will be collected. Images will be taken.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

• Age 18 and older
• Presenting for surveillance, screening or diagnostic colonoscopy
• Willingness to provide informed consent

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Exclusion Criteria

• Inability to provided informed consent
• Pregnancy
• Known inflammatory bowel disease
• Personal or family history of polyposis or nonpolyposis syndrome
• Emergency colonoscopy/endoscopy
• Coagulopathy or thrombocytopenia preventing polypectomy
• Procedure indication for acute bleeding or active colitis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of In Vivo determination of colorectal polyps histopathology	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes.	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States