Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01354873

Enrollment

556

Registered

2011-05-17

Start date

2011-01-31

Completion date

2013-08-31

Last updated

2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Polyps

Keywords

Colonoscopy, Colon Polyps

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results