Precise localization of small pulmonary nodules for sub-lobar resection in patients with early-stage lung cancer or suspected malignancy Surgery
Conditions
Interventions
For this interventional study, participants are randomized into two arms in a 1:1 ratio using block randomization with a block size of 4. The randomization sequence is generated using SAS software (ve
Sponsors
First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years who voluntarily participate in the trial and can personally sign the written informed consent 2. Presence of a solitary pulmonary nodule with a maximum diameter of less than 20 mm 3. The target nodule appears as a pure ground-glass opacity (GGO) or a mixed GGO (with a consolidation-to-tumor ratio<0.5), with clinical or radiological features suggestive of malignancy 4. The minimum distance from the outer edge of the nodule to the nearest pleural surface is greater than or equal to 5 mm 5. Cardiopulmonary function and other vital organ functions are generally normal, allowing the patient to tolerate surgery
Exclusion criteria
Exclusion criteria: 1. Patients who refuse to participate in the clinical trial 2. Pulmonary nodules located in the scapular region that limit percutaneous localization 3. Pulmonary nodules located near the mediastinum or major cardiac vessels 4. Patients with absolute contraindications to surgery, severe comorbidities, advanced disease, or other conditions deemed unsuitable for inclusion by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful resection rate for small pulmonary nodules, defined as achieving a resection margin that is equal to or greater than the diameter of the lesion or 2 cm, measured intraoperatively and confirmed by pathologic analysis during surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Margin distance: Measured intraoperatively on the excised specimen using a ruler or caliper. For confirmation, frozen section analysis may be performed to assess the distance between the nodule and the resection margin. 2. Conversion rate: Documented intraoperatively by the surgical team in the operation report, noting any conversions from VATS to open thoracotomy specifically due to localization challenges. 3. Intraoperative blood loss: Recorded intraoperatively by the anesthesiology team using suction canister measurements and surgical gauze weight, as documented in the anesthesia and surgical records. 4. Chest tube duration: Recorded in postoperative nursing records as the number of days from chest tube insertion to removal, based on daily clinical assessments of lung expansion and fluid output. 5. Hospital stay: Recorded in hospital discharge records as the total number of days from the date of admission for surgery to the date of discharge. 6. Localization-related complications: Documented intraoperatively and during the first 24 hours post-localization through clinical observations and imaging studies. Pneumothorax is assessed using chest X-rays or CT scans, pulmonary hemorrhage is identified during or after the procedure, and pain is measured using the visual analog scale (VAS) documented in patient records. 7. 30-day postoperative mortality: Assessed through follow-up via hospital records, outpatient visits, or direct patient or family contact. Any deaths occurring within 30 days of the surgical procedure are recorded. | — |
Countries
China
Contacts
Public ContactHengrui Liang
Outcome results
None listed