Early-Stage Lung Cancer, Pulmonary Nodules
Conditions
Keywords
ENB, CT-guided Percutaneous, pulmonary nodules, localization
Brief summary
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.
Interventions
PROCEDUREElectromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules
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.
PROCEDURECT-Guided Percutaneous Localization of Pulmonary Nodules
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.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years, regardless of gender; 2. Solitary single nodule, scheduled for lung nodule puncture and localization; 3. Chest CT (lung window mode) showing a maximum nodule diameter ≤ 2 cm; 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2; 5. Voluntary participation, with signed informed consent.
Exclusion criteria
1. Not suitable for video-assisted thoracoscopic surgery; 2. The distance between the center of the lesion and the dome of the diaphragm is \< 3 cm; 3. History of thoracic adhesion due to previous thoracotomy or pleural infection; 4. Patients judged by the investigator to be unsuitable for preoperative transthoracic or transbronchial localization; 5. Inability to complete follow-up or poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of intraoperative localization of lung nodules | Day 0 (Intraoperative) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Localization Accuracy | Day 0 (Intraoperative) | 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. |
| Location Procedure Time | Day 0 (Intraoperative) | 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). |
| Conversion Rate | Day 0 (Intraoperative) | 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). |
| Complication Rate | Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first | 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. |
| Radiation Exposure | Day 0 (Intraoperative) | Dose-length product (DLP) value of radiation received by the patient, as recorded by the CT scanner (unit: mGy·cm). |
| Operative Time | Day 0 (Intraoperative) | Time from the initiation of the skin incision for thoracoscopy to the completion of wound closure (unit: min). |
| Early Postoperative Pain Score | Day 0 (immediately after localization); 24 hours postoperatively | 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). |
Countries
China
Contacts
CONTACTShenghao Huang
PRINCIPAL_INVESTIGATORHaifeng Wang
Shanghai Pulmonary Hospital, Shanghai, China
Outcome results
None listed