ENB in the Diagnosis of Peripheral Pulmonary Nodules

Study Overview
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Brief Summary
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The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

Detailed Description
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The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.

Official Title
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Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules

Conditions
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Peripheral Pulmonary Nodules

Intervention / Treatment
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* Device: ENB
* Device: EBUS-GS


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) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy. Patients who agree to undergo bronchoscopy without any contraindications. Patients who have good compliance and sign informed consent. Exclusion Criteria: Chest CT scan shows that the pulmonary nodule is pure ground glass opacity. 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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENB-EBUS-GS group<br>ENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images. | Device: ENB<br>* ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.<br>Device: EBUS-GS<br>* EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).<br>|
| Active Comparator: EBUS-GS group<br>ENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images. | Device: EBUS-GS<br>* EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group | Diagnostic yield is defined as proportion of true positive and true negative. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of operation time between ENB-EBUS-GS group and EBUS-GS group | The operation time includes total operation time,total GS time and total EBUS time | one week | 
| The difference of complications between ENB-EBUS-GS group and EBUS-GS group | Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation | three months | 

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