This study aims to evaluate the clinical value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules, and to explore the value of mCBCT in improving the diagnostic yield by calculating the improvement in diagnostic yield of patients before and after mCBCT adjustments.
This study is a prospective, single-arm, single-center observational clinical trial to evaluate the diagnostic value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules. The investigators will adjust the position of electromagnetic navigation bronchoscopy base on the intraoperative 3D imaging findings of mCBCT. The value of mCBCT in improving diagnostic yield is explored by comparing the diagnostic yield Post-mCBCT with that of Pre-mCBCT. The Pre-mCBCT diagnostic yield is the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and with no need for adjustment after mCBCT spin confirmed "tool-in-lesion" during the procedure in all enrolled subjects. The Post-mCBCT diagnostic yield is the proportion of diagnosed patients with and without adjustment after mCBCT spin during the procedure in all enrolled subjects.
Study Type
OBSERVATIONAL
Enrollment
109
Subjects with biopsy of peripheral pulmonary nodule using electromagnetic navigation bronchoscopy and mobile cone-beam CT.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDiagnostic yield improvement ratio
Diagnostic yield improvement ratio, defined as Post-mCBCT diagnostic yield minus Pre-mCBCT diagnostic yield. The Pre-mCBCT diagnostic yield, defined as the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and without any adjustment after first time mCBCT spin during the procedure in all enrolled subjects. The Post-mCBCT diagnostic yield, defined as the proportion of diagnosed patients including those with and without adjustment after mCBCT spin in all enrolled subjects. Diagnostic yield was defined as all instances in which the results of bronchoscopy matched the final diagnoses.
Time frame: Up to at least 6 months
Pre-mCBCT navigational yield
The proportion of patients who was confirmed tool-in-lesion by the first time mCBCT spin and no need for further adjustment in all enrolled subjects.
Time frame: Intra-procedure
Post-mCBCT navigational yield
The proportion of patients who was confirmed tool-in-lesion with and without adjustment by mCBCT in all enrolled subjects.
Time frame: Intra-procedure
Total radiation dose
Radiation dose from procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm\^2).
Time frame: Intra-procedure
Fluoroscopy time
The fluoroscopy time during the procedure.
Time frame: Intra-procedure
Adjustment time
The adjustment time during the procedure, defined as the time between the first mCBCT spin scanning to final spin scanning.
Time frame: Intra-procedure
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Total operation time
The total operation time was defined as the time from bronchoscope insertion to withdrawal of the glottis.
Time frame: Intra-procedure
Factors affecting diagnostic yield
The factors affecting diagnostic yield includes the nodule nature, nodule size, nodule location, bronchus sign on CT, etc.
Time frame: Up to at least 6 months
Complication rate
The complications refer to the proportion of serious adverse events related to the procedure during or within 1 month after the operation.
Time frame: Up to 1 month