Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

Sponsor
Soon Chun Hyang University (Other)
Overall Status
Completed
CT.gov ID
NCT01133041
Collaborator
(none)
142
1
2
5
28.2

Study Details

Study Description

Brief Summary

Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax).

Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias.

To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps.

The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps.

In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems.

Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation using NBI system
  • Other: Observation using i-Scan system
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
142 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: NBI observation

Other: Observation using NBI system
NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Other Names:
  • NBI, narrow band imaging (Olympus, Japan)
  • Experimental: i-Scan observation

    Other: Observation using i-Scan system
    I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.
    Other Names:
  • i-Scan (Pentax, Japan)
  • Outcome Measures

    Primary Outcome Measures

    1. Diagnostic efficacy [about 1 year]

      Sensitivity, specificity, and diagnostic accuracy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • screening or surveillance colonoscopy

    • age over 18

    • informed consent

    Exclusion Criteria:
    • history of inflammatory bowel diseases

    • history of hereditary colorectal cancers and polyposis syndrome

    • inability to give informed consent

    • use of antiplatelet agent and anticoagulants

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soon Chung Hyang University, Cheonan hospital Cheonan Choongnam Korea, Republic of 330-721

    Sponsors and Collaborators

    • Soon Chun Hyang University

    Investigators

    • Principal Investigator: Chang Kyun Lee, MD, PhD, Soon Chun Hyang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chang Kyun Lee, MD, PhD, Soon Chun Hyang University
    ClinicalTrials.gov Identifier:
    NCT01133041
    Other Study ID Numbers:
    • SCHCH2010L2
    First Posted:
    May 28, 2010
    Last Update Posted:
    Sep 27, 2011
    Last Verified:
    May 1, 2010
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 27, 2011