Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

Intestinal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577875
• Other study ID #: NBI_Zoom_CVS_01
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: November 18, 2014
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with colorectal polyps which are in need of EMR

Exclusion Criteria:

• pregnancy, IBD, colorectal cancer, etc.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intestinal Polyps

Intervention

Device:
• NBI with magnification
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.

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Jongno-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification	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.	After 1 week	No
Secondary	Sensitivity of the endoscopic histologic prediction with NBI plus magnification	Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity.	1 Week	No
Secondary	Specificity of the endoscopic histologic prediction with NBI plus magnification	Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of specificity.	1 Week	No
Secondary	Positive predictive value of the endoscopic histologic prediction with NBI plus magnification	Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of positive predictive value.	1 Week	No
Secondary	Negative predictive value of the endoscopic histologic prediction with NBI plus magnification	Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value.	1 Week	No