Prospective Cohort of Electromagnetic Navigation Bronchoscopy

Study Overview
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Brief Summary
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The primary objective is To evaluate the usefulness and safety of 3D electromagnetic navigation bronchoscopy for histological diagnosis of peripheral pulmonary lesions The Secondary objective is to establish a strategy that can most effectively use navigation endoscopes for early diagnosis of lung cancer in a real-world care environment by identifying patient/clinical/image/procedure-related characteristics that can optimize the practicality of this technology.

Detailed Description
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Patients with peripheral pulmonary lesions who need histological diagnosis due to suspected lung cancer and whose lesions are judged capable of histological examination through 3D electromagnetic navigation bronchoscopy will be prospectively recruited. This study is a pure non-interventional pragmatic design. In addition to biopsy for lung lesions using navigation, lung cancer staging and tests necessary for metastases and treatment for diagnosed lung cancer are performed according to existing guidelines and the judgment of medical staff. We will analyze the clinical characteristics of navigational bronchoscopy procedures used in clinical practice and the main results during the follow-up period of up to one year (diagnostic yield, sensitivity, safety, practicality, and various factors affecting usefulness).

Official Title
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Korean Multicenter Prospective Cohort of Electromagnetic Navigation Bronchoscopy

Conditions
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Suspected Lung Cancer

Intervention / Treatment
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* Device: 3D electromagnetic navigation guided bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who agreed in writing to participate in this study Adult men and women over 19 years of age Patients who visited the hospital with lung lesions suspected of lung cancer and require a diagnostic biopsy Patients capable of biopsy through 3D electromagnetic navigation bronchoscopy Exclusion Criteria: 1) Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| single group<br>Patients with peripheral pulmonary lesions which require histological differentiation because of the possibility of malignancy, and a biopsy can be attempted through 3D electromagnetic navigation bronchoscopy | Device: 3D electromagnetic navigation guided bronchoscopy<br>* It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.<br>* Other names: Device: Spin Thoracic Navigation System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield at index | The proportion of pathologic results that leads to a specific malignant or benign | Upon reports of pathologic results (up to 2 weeks after bronchoscopy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield at 12 months | True positive + True negative (confirmed benign with follow-up of at least 1yr without progression) / Total procedures Pathologic results of a malignant or benign specific diagnosis based on the samples collected via index ENB procedure are categorized as true positives or true negatives. For pathologic results of a benign non-specific diagnosis and non-diagnostic results, follow-up data would be used to determine whether the 12-month status corroborates the benign results. Based on definition scenarios, these results will be determined as true negatives or false negatives. Diagnostic yields based on different scenarios will be reported. | Confirmed by follow-up results at 1 year | 
| Sensitivity for malignancy | True positive/Confirmed malignancy cases | Confirmed by follow-up results at 1 year | 
| Complication | Evaluate complications due to 3D electromagnetic navigation bronchoscopy | Confirmed by follow-up results at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Diagnosis