Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

Study Overview
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Brief Summary
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This study evaluates the value of different bronchoscopy combination for diagnosing peripheral pulmonary lesions suspected to be cancer. One-third of participants will receive routine bronchoscopy, while one-third of participants will receive bronchoscopy combined with a guiding equipment and the other one-third of participants will receive bronchoscopy combined with two or more guiding equipments. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy.

Official Title
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Prospective Multicenter Randomized Control Study on Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

Conditions
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Lung Neoplasms, Early Diagnosis, Bronchoscopy

Intervention / Treatment
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* Procedure: guiding equipments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible subjects are adults with solitary peripheral pulmonary lesions (mean diameter, ≤30mm and >8mm from axial CT images) suspected to be cancer but were not pathologically confirmed. 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 of 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. 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Bronchoscopy<br>Participants in the group will receive routine bronchoscopy. | |
| Experimental: Routine Bronchoscopy with a guiding equipment<br>Participants in the group will receive routine bronchoscopy combined with a guiding equipment. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy. | Procedure: guiding equipments<br>* The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.<br>|
| Experimental: Routine Bronchoscopy with two or more guiding equipments<br>Participants in the group will receive routine bronchoscopy combined with two or more guiding equipments. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy. | Procedure: guiding equipments<br>* The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield for pulmonary peripheral lesions | The diagnostic yield for individuals with pulmonary peripheral lesions examined by bronchoscopy with or without guiding equipments | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of operation time using bronchoscopy or bronchoscopy combination | The operation time using bronchoscopy or bronchoscopy combination to examine a participant | 30 minutes | 
| length of stay in hospital | length of stay in hospital for a participant | 7 days | 
| hospitalization costs | the hospitalization costs for a participant | 7 days | 
| Number of participants with adverse events or serious adverse events | Number of participants with any adverse events or serious adverse events | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Neoplasms, Bronchoscopy, Virtual Bronchoscopic Navigation(VBN), Fluoroscopy, Endobronchial Ultrasonography with a Guide Sheath(EBUS-GS), Diagnosis