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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
436
VBN is carried out by a VBN software（DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.
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).
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.
Shanghai Chest Hospital
Shanghai, China
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
Time frame: one year
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
Time frame: 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
Time frame: one year
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