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The study is designed as a multi-center prospective trial of ENB for the diagnosis of peripheral pulmonary nodules in the real world. The purpose of the study is to identify the optimal method of using ENB.
The study will be conducted at no less than 5 clinical centers. Patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well. The primary endpoint is the diagnostic yield of ENB. The secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.
ENB is carried out by a ENB system（LungCare, China) with/without other guided bronchoscopy techniques and/or ROSE, which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
Diagnostic yield is defined as proportion of true positive and true negative. The primary endpoint is diagnostic yield of ENB with/without other guided bronchoscopy techniques or ROSE.
Secondary Outcome Measures :
The difference of diagnostic yield among groups of different methods of using ENB [ Time Frame: One year ]
ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well.The difference of diagnostic yield among groups of different methods of using ENB will be analyzed.
Factors affecting diagnostic yield [ Time Frame: One year ]
Factors affecting diagnostic yield including lesion size,bronchus sign, location and so on will be analyzed.
The difference of diagnostic yield among groups using different locatable guides [ Time Frame: One year ]
There are three kinds of locatable guides with different outer diameters. The difference of diagnostic yield among groups using different locatable guides will be analyzed.
Operation time [ Time Frame: One year ]
Operation time includes total operation time,total GS time and total EBUS time.
Incidence of complications [ Time Frame: One year ]
Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who meet inclusion/exclusion criteria will be enrolled in the study consecutively in each clinical center.
Patients who are older than 18 year-old.
Chest CT shows peripheral pulmonary nodule (8mm＜longest diameter≤30mm) suspicious for malignant that needs to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible with standard bronchoscopy.
Patients who agree to undergo bronchoscopy without any contraindications.
Patients who have good compliance and sign informed consent.
Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.