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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
  Purpose

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 Intervention Phase
Diminutive Colon Polyp
Adenomatous Polyp
Hyperplastic Polyp
Colonoscopy
Other: Observation using NBI system
Other: Observation using i-Scan system
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps

Resource links provided by NLM:


Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • Diagnostic efficacy [ Time Frame: about 1 year ] [ Designated as safety issue: No ]
    Sensitivity, specificity, and diagnostic accuracy


Enrollment: 142
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NBI observation 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)
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 Name: i-Scan (Pentax, Japan)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01133041

Locations
Korea, Republic of
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
  More Information

Publications:
Responsible Party: Chang Kyun Lee, MD, PhD, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT01133041     History of Changes
Other Study ID Numbers: SCHCH2010L2
Study First Received: May 27, 2010
Last Updated: September 26, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Adenomatous Polyps
Colonic Polyps
Hyperplasia
Polyps
Adenoma
Intestinal Polyps
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014