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

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01178190
First received: July 28, 2010
Last updated: August 9, 2010
Last verified: June 2010
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Chang Min ,Choi, Asan medical center
ClinicalTrials.gov Identifier: NCT01178190     History of Changes
Other Study ID Numbers: NBI-AMC
Study First Received: July 28, 2010
Last Updated: August 9, 2010
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014