The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.
This is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 186 participants planned for enrollment. Subjects with peripheral pulmonary nodules (PPNs) suspected of malignancy, requiring non-surgical biopsy detected by chest CT will be included in this study. Firstly, the physician will determine the lesion to be biopsied, then the subject will be randomly assigned to either the experimental or control group. The experimental group will undergo the procedure using the robotic-assisted bronchoscopy system and catheters, developed by Changzhou Langhe Medical Devices Co., Ltd. for the localization and sampling of PPNs. The control group will undergo ultrathin bronchoscopy guided by virtual bronchoscopic navigation. Radial endobronchial ultrasound (r-EBUS) will be available for all procedures. If the physician determines that biopsy sampling is feasible, a transbronchial lung biopsy will be performed. The primary endpoint is the intermediate definition of diagnostic yield. Secondary endpoints include navigation success yield, arrival time, incidence of complications, and strict definition of diagnostic yield.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
186
Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
Utilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
Shandong Public Health Clinical Center
Jinan, Shandong, China
RECRUITINGRuijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Diagnostic yield
Intermediate definition of diagnostic yield=(Number of procedures with a specific malignant or benign pathological diagnosis+Number of procedures with nonspecific benign diagnoses that turn out to be nonmalignant at follow-up)/Total number of patients in whom the minimally invasive procedure was attempted or performed\*100%
Time frame: 14 days post-procedure
Navigation success yield
Navigation success yield = (number of nodules successfully navigated / total number of nodules biopsied by bronchoscopy in each group) \* 100%
Time frame: During the procedure
Navigation time
In the experimental group, the navigation time is measured from the tracheal carina after the registration to the moment the lesion is visible at the front-end camera of the catheter or confirmed by r-EBUS. In the control group, the navigation time is measured from the tracheal carina to the moment the lesion is confirmed by r-EBUS.
Time frame: During the procedure
Incidence of complications
Incidence of complications = (number of cases with complications / total number of sampled cases) \* 100%. Complications are categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and include events such as pneumothorax and bleeding.
Time frame: 14 days post-procedure
Strict definition of diagnostic yield
Strict definition of diagnostic yield=(Number of procedures with a specific malignant or benign pathological diagnosis)/Total number of patients in whom the minimally invasive procedure was attempted or performed\*100%
Time frame: 14 days post-procedure
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Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGSir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITING