This study aims to design and conduct a multicenter, prospective, randomized controlled post-market clinical trial to validate the clinical efficacy of high-precision electromagnetic navigation technology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Performed by an experienced thoracic surgeon or interventional radiologist under general or local anesthesia, the procedure is guided by an electromagnetic navigation system. The procedural steps include: 1) preoperative import of the patient's CT data into the navigation system for path planning; 2) intraoperative coupling of the positioning sensor with the puncture instrument; 3) under real-time three-dimensional imaging guidance of the electromagnetic navigation system, performing percutaneous puncture to accurately place a positioning guidewire / microcoil / dye near the target pulmonary nodule; 4) postoperative CT scan to confirm the localization. This is a single-session procedure.
Performed by an experienced thoracic surgeon or interventional radiologist under local anesthesia, the procedure is guided using a CT scanner. The steps include: 1) positioning the patient appropriately and performing a CT scan to determine the puncture site and path; 2) employing CT fluoroscopy or intermittent CT scanning for real-time guidance; 3) under CT image guidance, performing a percutaneous puncture to place a localization guidewire / microcoil / dye near the target pulmonary nodule; 4) performing a repeat CT scan post-procedure to confirm the localization position. This is a single-session procedure.
Shanghai Pulmonary Hospital
Shanghai, China
Success rate of intraoperative localization of lung nodules
Thoracoscopic exploration enables accurate identification and localization of markers (e.g., contrast dye, microcoils, etc.), with the distance between the center of the marker or the main imaging area and the center of the target nodule being ≤20 mm, and ultimately successfully guides the resection of the target lesion.
Time frame: Day 0 (Intraoperative)
Localization Accuracy
The shortest physical distance (unit: mm) between the actual localization marker point (e.g., the center of the dye) and the outer edge of the nodular lesion in the resected specimen.
Time frame: Day 0 (Intraoperative)
Location Procedure Time
CT-guided group: Time from the start of the initial localization planning CT scan to the completion of marker/needle deployment and withdrawal of instruments from the body surface. Electromagnetic navigation group: Time from when the bronchoscope passes the vocal cords to the completion of marker deployment and withdrawal of the guiding instrument (unit: min).
Time frame: Day 0 (Intraoperative)
Conversion Rate
The proportion of subjects in whom conversion from complete thoracoscopy to thoracotomy, or from the planned sublobar resection (wedge/segment) to an extended resection (e.g., lobectomy), was necessitated due to failure to locate the lesion, insufficient surgical margin resulting from excessive localization error, or severe complications related to localization (such as major hemorrhage).
Time frame: Day 0 (Intraoperative)
Complication Rate
Record the incidence of all complications related to the localization procedure. In addition to complications common to percutaneous approaches, such as pneumothorax and intrathoracic hemorrhage, airway-related complications, including airway mucosal injury/bleeding, bronchospasm, and severe hypoxemia, should be systematically documented. Assessment should be performed based on the adverse event grading criteria.
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Time frame: Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first
Radiation Exposure
Dose-length product (DLP) value of radiation received by the patient, as recorded by the CT scanner (unit: mGy·cm).
Time frame: Day 0 (Intraoperative)
Operative Time
Time from the initiation of the skin incision for thoracoscopy to the completion of wound closure (unit: min).
Time frame: Day 0 (Intraoperative)
Early Postoperative Pain Score
Visual Analog Scale (VAS) or Numeric Rating Scale (NRS), scored from 0 to 10 points (with 0 representing no pain and 10 representing the most severe pain).
Time frame: Day 0 (immediately after localization); 24 hours postoperatively