Overview
Whether tubeless anesthesia provides clinically superior postoperative symptom recovery (measured by PSA-LUNG) and higher safety in patients undergoing VATS combined with microwave ablation (VATS+MWA)
Description
This study is a multicenter, prospective, randomized controlled interventional clinical trial conducted by the Department of Thoracic Surgery at The First Affiliated Hospital of Guangzhou Medical University. The study primarily compares the efficacy and safety of tubeless anesthesia versus conventional endotracheal intubation anesthesia in video-assisted thoracoscopic surgery (VATS) combined with simultaneous microwave ablation (MWA) for the treatment of multiple high-risk pulmonary ground-glass nodules (GGNs), with the Postoperative Symptom Assessment scale for lung cancer surgery (PSA-LUNG)-a patient-reported outcome-as the core evaluation indicator.
A total of 80 patients with multiple high-risk GGNs who meet the inclusion criteria will be randomly assigned in a 1:1 ratio to two groups: the experimental group will undergo VATS combined with MWA under tubeless anesthesia, while the control group will undergo VATS combined with MWA under conventional intubation anesthesia. By assessing the PSA-LUNG score, technical success rate, perioperative complication rate, and postoperative changes in lung function, this study aims to determine whether tubeless anesthesia can provide patients with better postoperative symptom recovery and higher safety. Meanwhile, the dynamic changes in tumor markers will be explored to provide clinical evidence for optimizing perioperative anesthesia strategies in this patient population.
Eligibility
Inclusion Criteria:
- aged ≥ 18 years
- Chest CT revealed ≥2 multiple high-risk pulmonary ground-glass nodules (GGNs) that persisted for over 3 months. Following a multidisciplinary team (MDT) evaluation, these nodules were highly suspicious for malignancy. The nodules were required to meet the following criteria: Imaging criteria: Maximum diameter ≤2 cm and a consolidation-to-tumor ratio (CTR) ≤0.5 on chest CT. Surgical nodule criteria: Deemed amenable to wedge resection via intrathoracic surgical evaluation, with an anticipated surgical margin of ≥2 cm or ≥ the maximum diameter of the nodule. Ablation nodule criteria: Deemed unsuitable for wedge resection via intrathoracic surgical evaluation, primarily due to a location within the inner two-thirds of the lung parenchyma.
- ECOG performance status: 0-1; preoperative systemic organ function was adequate for VATS and ablation.
- ASA physical status: Class I-III
- Preoperative PET-CT or other necessary imaging tests to exclude mediastinal and distant metastasis.
- Expected survival ≥ 6 months; able to complete the study and follow-up as required.
- Participants provided written informed consent and agreed to adhere to study visits, treatments, laboratory tests and related procedures.
Exclusion Criteria:
- Prior pulmonary surgery, radiotherapy or other ablation within 3 months.
- Contraindications to surgery, ablation or anesthesia; intolerance to tubeless anesthesia.
- Planned concurrent treatments interfering with study results (e.g., systemic chemotherapy, targeted therapy).
- Primary extrapulmonary malignancies or other active malignant diseases.
- Failure to follow study rules or complete follow-up; refusal to provide informed consent or withdrawal of consent during the study.
- Considered unsuitable for the study by investigators.
- Enrollment in other concurrent clinical trials.
