Application of Electromagnetic Navigation System in Pulmonary Nodule Localization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years, regardless of gender;
Solitary single nodule, scheduled for lung nodule puncture and localization;
Chest CT (lung window mode) showing a maximum nodule diameter ≤ 2 cm;
Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
Disqualifiers
Not suitable for video-assisted thoracoscopic surgery;
The distance between the center of the lesion and the dome of the diaphragm is < 3 cm;
History of thoracic adhesion due to previous thoracotomy or pleural infection;
Patients judged by the investigator to be unsuitable for preoperative transthoracic or transbronchial localization;
Trial design
Design model
Parallel
Treatments tested in this trial
Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules
Procedure/SurgeryPerformed 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.
CT-Guided Percutaneous Localization of Pulmonary Nodules
Procedure/SurgeryPerformed 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Electromagnetic Navigation Localization GroupExperimental treatment 1 intervention
Group B: CT-Guided Localization GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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.
Time frame
Day 0 through hospital discharge or Day 7 postoperatively, whichever comes firstSponsors and contacts
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Source ClinicalTrials.gov
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