VBN-EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility, efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing by using virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

Detailed Description
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The investigators evaluate the feasibility, efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing by using virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a three centers prospective randomized controlled trial.The participating centers are Department of endoscopy , Shanghai chest Hospital, Shanghai JiaoTong University, China. Department of endoscopy, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, China. Department of Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University, China. Patients are divided into two groups, VBN-EBUS-GS-X-ray group and VBN-EBUS-GS group. Each subject will be randomized to each group. The study is expected to enroll 436 patients at 3 centers.

Official Title
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Diagnostic Value of Virtual Bronchoscopic Navigation (VBN) Combined With Endobronchial Ultrasound (EBUS) With a Guide Sheath (GS) for Peripheral Pulmonary Lesions (PPLs) Without Fluoroscopy: a Randomized Controlled Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: VBN
* Device: EBUS-GS
* Device: X-ray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 8mm and non GGO lesions. Exclusion Criteria: Absence of bronchus leading to or adjacent to the lesion from CT scan Refusal of participation Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy Presence of concomitant endobronchial lesion during the brochoscopy procerdure

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: VBN-EBUS-GS group<br>Fluoroscopy are not used in this group. EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance. | Device: VBN<br>* VBN is carried out by a VBN software（DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.<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: VBN-EBUS-GS-X-ray group<br>EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained with fluoroscopic guidance. | Device: VBN<br>* VBN is carried out by a VBN software（DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.<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>Device: X-ray<br>* The radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of diagnostic value of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB | The diagnostic value means sensitivity and specificity in two groups | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of operation time of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB | The operation time includes total operation time,total GS time and total EBUS time | one year | 
| The difference of complications of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB | 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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Virtual bronchoscopic navigation, Endobronchial ultrasound, Guide Sheath, Transbronchial biopsy, Peripheral pulmonary lesions