ENB for the Diagnosis of PPNs:a Real World Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study

Conditions
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Peripheral Pulmonary Nodules

Intervention / Treatment
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* Procedure: Electromagnetic navigation bronchoscopy (ENB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Presence of concomitant endobronchial lesion during the brochoscopy procerdure. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Procedure: Electromagnetic navigation bronchoscopy (ENB)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of diagnostic yield among groups of different methods of using ENB | 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. | One year | 
| Factors affecting diagnostic yield | Factors affecting diagnostic yield including lesion size,bronchus sign, location and so on will be analyzed. | One year | 
| The difference of diagnostic yield among groups using different locatable guides | 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. | One year | 
| Operation time | Operation time includes total operation time,total GS time and total EBUS time. | One year | 
| Incidence of complications | Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic yield, electromagnetic navigation bronchoscopy(ENB), peripheral pulmonary nodules