The purpose of this study is to evaluate the performance and safety of electromagnetic navigation bronchoscopy (ENB) system and system kit (iLungTM SuperNavigator) .
This is prospective, randomized, multicenter, superiority study. 8 top centers in China was chosen. Subject which has peripheral lung lesions (PLLs) detected by chest CT scan, requires biopsy diagnosis, and meets all inclusion and exclusion criteria, will be included in this trial. Firstly physician determines the lesion biopsied, then the subject will be randomized to experimental or control group. The experimental group is treated with ENB guided transbronchial lung biopsy (TBLB)(ENB-TBLB): Under ENB guidance, the location sensor reaches the edge of the lesion, and X-ray is used for actual distance confirmation, if physician determines the distance is enough for biopsy, TBLB will be conducted. The control group will be treated with TBLB using X-ray guidance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
226
ENB Guidance: The iLungTM SuperNavigator system will be used, it comprises of iLungTM ENB system, location catheter and guide catheter. The guide catheter can supply a 1.9 mm working channel for biopsy tools. The location catheter is inserted into the guide catheter beforehand, then both are introduced via the working channel of the bronchoscope. Under guidance of ENB system, the location catheter reaches the lesion, and actual distance is confirmed by the X-ray. TBLB: Location catheter is retracted, then the biopsy forceps and brush was introduced, and pathologic specimens are obtained.
Based on chest CT, the physician determines the lesion location. Under X-ray guidance, via the bronchoscope's working channel, the biopsy forceps and brush are introduced and pathologic specimens are obtained.
Cancer Hospital, Chinese Academy of Medical sciences
Beijing, Beijing Municipality, China
The second affiliated hospital, Fujian Medical University
Quanzhou, Fujian, China
The First Affiliate Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB
Diagnostic yield = Lesions with definitive diagnosis /total lesions with biopsies. Comment: Lesions with definitive diagnosis: 1. Biopsy pathologic results show as benign or malignant lesion (fungi, tuberculosis, or nodule disease,etc.); 2. Biopsy pathologic results are abnormal lung tissue, but through later diagnosis, treatment and other observation measures, the lesion is proved to be benign; 3. When the patient cannot be diagnosed after a 6-month following-up, a CT or enhanced CT scan is needed and the physician make a final diagnosis based on the scan results.
Time frame: Up to 6 months
Incidence of navigation success
This outcome just apply to experimental group. Incidence of navigation success = the number of lesions navigated successfully/total lesions with ENB procedure × 100%. Criteria for navigation success: When the navigation software shows the distance of location sensor to the target ≤10mm, using X-ray to confirm the actual distance, if the physician determine that biopsy can be conducted, the navigation is successful, if not, the navigation fails.
Time frame: At 1 day of ENB procedure
Lesion detection rate
Based on the biopsy pathologic results, evaluate the lesion detection rate of experimental and control group. Lesion detection rate = Total lesions detected / Total lesions with biopsies. Comment: 'Lesions detected' indicates pathologic result shows as abnormal lung tissue.
Time frame: About 3-7days after ENB or X-ray procedure
Navigation time
Evaluate navigation time of experimental and control group. Experimental group: After registration, the location sensor returns the carina. Navigation begins from the carina and ends when the sensor reaches the edge of the lesion, which is verified by the X-ray. This period is defined as navigation time of experimental group. Control group: Under X-ray guidance, the bronchoscope moves from the carina to the edge of the lesion. This period is defined as navigation time of control group.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The first affiliated hospital of Suzhou University
Suzhou, Jiangsu, China
Shanghai Chest hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
The first affiliated hospital, Zhejiang university
Hangzhou, Zhejiang, China
Time frame: At 1 day of ENB or X-ray procedure
Evaluate the user satisfaction of ENB system and system kit
After each ENB procedure, the investigator evaluate the operational performance of ENB system and system kit through a pre-designed questionnaire which includes terms related to the device function, convenience, reliability and safety.
Time frame: At 1 day of ENB procedure
The adverse events and device defects related to the ENB system and system kit
Adverse events: Include incidence of pneumothorax, bleeding, respiratory failure, etc.
Time frame: Up to 3 days