Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01577875
First received: April 10, 2012
Last updated: April 15, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Intestinal Polyps
Device: NBI with magnification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification [ Time Frame: After 1 week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Sensitivity of the endoscopic histologic prediction with NBI plus magnification [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value.


Estimated Enrollment: 122
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
histologic prediction only with the narrow band imaging (without magnification)
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.
Other Name: Narrow band image with magnification
No Intervention: test group
histologic prediction with narrow band imaging plus magnification

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with colorectal polyps which are in need of EMR

Exclusion Criteria:

  • pregnancy, IBD, colorectal cancer, etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577875

Contacts
Contact: Kyoung Sup Hong, MD 82 (02)2072-0360 kshong1@empal.com

Locations
Korea, Republic of
SNUH Recruiting
Jongno-gu, Seoul, Korea, Republic of, 110-744
Contact: Kyung sup Hong, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kyoung Sup Hong, MD SNUH Internal Medicine
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01577875     History of Changes
Other Study ID Numbers: NBI_Zoom_CVS_01
Study First Received: April 10, 2012
Last Updated: April 15, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014