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Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Kyun Lee, Soon Chun Hyang University
ClinicalTrials.gov Identifier:
NCT01133041
First received: May 27, 2010
Last updated: September 26, 2011
Last verified: May 2010
History of Changes

May 27, 2010
September 26, 2011
May 2010
October 2010   (final data collection date for primary outcome measure)
Diagnostic efficacy [ Time Frame: about 1 year ] [ Designated as safety issue: No ]
Sensitivity, specificity, and diagnostic accuracy
Same as current
Complete list of historical versions of study NCT01133041 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps
Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Diminutive Colon Polyp
  • Adenomatous Polyp
  • Hyperplastic Polyp
  • Colonoscopy
  • Other: Observation using NBI system
    NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
    Other Name: NBI, narrow band imaging (Olympus, Japan)
  • Other: Observation using i-Scan system
    I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.
    Other Name: i-Scan (Pentax, Japan)
  • Experimental: NBI observation
    Intervention: Other: Observation using NBI system
  • Experimental: i-Scan observation
    Intervention: Other: Observation using i-Scan system

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01133041
SCHCH2010L2
Yes
Chang Kyun Lee, Soon Chun Hyang University
Soon Chun Hyang University
Not Provided
Principal Investigator: Chang Kyun Lee, MD, PhD Soon Chun Hyang University Cheonan Hospital
Soon Chun Hyang University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP