The purpose of this study is to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) .
The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope department, Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University, China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray group.Each subject will be randomized to each group.The study is expected to enroll 60 patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.
A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
Shanghai Chest Hospital
Shanghai, China
The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.
Time frame: Up to half year
The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone
Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.
Time frame: Up to half year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.