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NBI: The Role of Narrow Band Imaging Videobronchoscopy in Lung Cancer

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01178190
Collaborator
(none)
101
Enrollment
1
Location
11
Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Narrow band imaging (NBI) videobronchoscopy is an optical technique in which filtered light enhances superficial neoplasm based on their neoangiogenic pattern. The objectives of this study investigate its better diagnostic yield in the assessment of lung cancer than conventional flexible bronchoscopy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Inspection with high resolution endoscopy was followed by NBI. Detected lesions were biopsied. applied the system of shibuya et al. to analyze and classify vascular patterns by NBI into four categories (spiral and screw pattern, dotted pattern, tortuous pattern, avascular pattern) compared with the known diagnostic yield of conventional white light bronchoscopy, An equivalent or superior result will also significantly impact on patient care This technology could aid not only early-stage lung cancer diagnosis but also more accurate local staging of lung cancer.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    101 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Diagnostic Yield of Narrow Band Imaging Videobronchoscopy in Lung Cancer
    Study Start Date :
    Jul 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Jun 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    lung cancer

    Outcome Measures

    Primary Outcome Measures

    1. accuracy of NBI videobronchoscopic biopsy [10-11 months]

      Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies for the diagnostic techniques for lung cancer.

    Secondary Outcome Measures

    1. early cancer lesion detection rate using Shibuya descriptors [10-11 months]

      Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies for the diagnostic techniques for early lung cancer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • endobronchial lesion on chest CT
    Exclusion Criteria:

    • Age < 18 years old

    • Inability to consent for the study

    • Inability to tolerate bronchoscopy

    • Active pulmonary infection (bronchitis, pneumonia)

    • ST elevation or depression on ECG

    • Prothrombin time prolongation(<70%)

    • platelet <10,000

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ChangMin, Choi Seoul Korea, Republic of

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    • Principal Investigator: ChangMin Choi, M.D., Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01178190
    Other Study ID Numbers:
    • NBI-AMC
    First Posted:
    Aug 10, 2010
    Last Update Posted:
    Aug 10, 2010
    Last Verified:
    Jun 1, 2010
    Keywords provided by , ,
    narrow band imaging
    malignant lesion
    lung cancer
    NBI
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Aug 10, 2010