Role of Bronchoscopy in Early Lung Cancer Screening of High Risk Population

Study Overview
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Brief Summary
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The purpose of this study is to determine the diagnostic yield of early lung cancer in high risk population, who smokes or has other risk factors, by different bronchoscopy,. Furthermore, another purpose is to determine whether the different bronchoscopy are significant different in diagnosing early lung cancer.

Official Title
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A Multi-center Randomized Control Study of Bronchoscopy in Early Lung Cancer Screening of High Risk Population

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Procedure: Fluorescence Bronchoscopy/Narrow Band Bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is over 40 years in age and is a heavy cigarette smoker.(smoking index is over 400) Patient has been coughing irritably for 2-3 weeks with a failed treatment and without obvious causes. The nature of cough changes in a patient who has chronic respiratory disease. Patient has blood-stained sputum persistently or repeatedly without obvious causes. Patient will be included if accorded with any item of above. Exclusion Criteria: Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise. Patient has uncontrollable hypertension (SBP > 180mmHg). Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc). Patient has blood coagulation disorders (PT>2 times the upper limit of normal(ULN) or Platelet(PLT)<50000/ul）. Patient has severe dyspnea. Patient is allergic to local anesthetic. Patient is unable to provide informed consent. Patient is not an appropriate candidate for or is unable to tolerate flexible bronchoscopy procedures. Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints. Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures. Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study. Patient has pulmonary lesions suspected to be cancer from CT images. Female patient of childbearing potential has a positive result from a pregnancy test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fluorescence/Narrow Band Bronchoscopy<br>All patients in the group are examined by Fluorescence Bronchoscopy and Narrow Band Bronchoscopy to make a early detection of lung cancer. | Procedure: Fluorescence Bronchoscopy/Narrow Band Bronchoscopy<br>* Fluorescence Bronchoscopy and Narrow Band Bronchoscopy are used in the Fluorescence/Narrow Band Bronchoscopy group to make a diagnosis of lung cancer.<br>|
| Routine Bronchoscopy<br>All patients in this group are examined by routine bronchoscopy to make a early detection of lung cancer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of Lung Cancer |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious Adverse Events |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Neoplasms, Bronchoscopy, Early Detection of Cancer