The Role of Narrow Band Imaging Videobronchoscopy in Lung Cancer

Lung Cancer Clinical Trial

— NBI  

Official title:

The Diagnostic Yield of Narrow Band Imaging Videobronchoscopy in Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178190
• Other study ID #: NBI-AMC
• Status: Completed
• Phase: N/A
• First received: July 28, 2010
• Last updated: August 9, 2010
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	ChangMin, Choi	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of NBI videobronchoscopic biopsy	Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies for the diagnostic techniques for lung cancer.	10-11 months	No
Secondary	early cancer lesion detection rate using Shibuya descriptors	Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies for the diagnostic techniques for early lung cancer.	10-11 months	No