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The Role of Narrow Band Imaging Videobronchoscopy in Lung Cancer (NBI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178190
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asan Medical Center
  Purpose
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
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Diagnostic Yield of Narrow Band Imaging Videobronchoscopy in Lung Cancer

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • accuracy of NBI videobronchoscopic biopsy [ Time Frame: 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:
  • early cancer lesion detection rate using Shibuya descriptors [ Time Frame: 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.


Enrollment: 101
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
lung cancer

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
suspected endobroncheal lesion on chest CT
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178190


Locations
Korea, Republic of
ChangMin, Choi
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: ChangMin Choi, M.D. Asan Medical Center
  More Information

Responsible Party: Chang Min ,Choi, Asan medical center
ClinicalTrials.gov Identifier: NCT01178190     History of Changes
Other Study ID Numbers: NBI-AMC
First Submitted: July 28, 2010
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
Last Verified: June 2010

Keywords provided by Asan Medical Center:
narrow band imaging
malignant lesion
lung cancer
NBI

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases