To assess the efficacy and safety of robotic-assisted bronchoscopy system (bronchial navigation and positioning device) combined with ICNVA strategy for peripheral pulmonary nodule biopsy through a prospective, single-center, single-arm study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
1. Preoxygenation \& Navigation Registration 2. Robotic-Guided Navigation 3. Puncture Tunnel Establishment 4. Position Verification \& Adjustment Perform confirmatory CT scan to assess tool-nodule relationship: Tool-in-lesion (TIL) : Biopsy tool penetrates nodule Center Strike : Tool tip reaches central 1/3 of nodule (coronal/sagittal/horizontal planes) Tool-touch-lesion : Tool contacts but does not enter nodule * 4mm deviation : Proceed to biopsy \>4mm deviation : Adjust based on operator judgment 5. Biopsy \& Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps 6. Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Tool-in-lesion rate
Time frame: Perioperative/Periprocedural
Center Strike rate
Time frame: Perioperative/Periprocedural
Tool-touch-lesion rate
Time frame: Perioperative/Periprocedural
Successful diagnosis rate
Time frame: Perioperative/Periprocedural
Lesion detection rate
Time frame: Perioperative/Periprocedural
Bronchopulmonary hemorrhage rate
Time frame: Perioperative/Periprocedural
Pneumothorax rate
Time frame: Perioperative/Periprocedural
CT to Body divergence(CTBD)
The difference between the distance from the probe to the center of the target nodule in Robotic-Assisted Bronchoscopy and the actual distance from the probe to the target nodule center in follow-up Computed Tomography
Time frame: Perioperative/Periprocedural
Successful operation rate
Time frame: Perioperative/Periprocedural
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