Video-Assisted Thoracoscopic Surgery Combined With Radiofrequency Ablation Versus VATS Alone for Multiple Primary Lung Cancer

This multicenter randomized controlled trial will compare two surgical approaches for patients with synchronous ipsilateral multiple primary lung cancer, meaning two or more primary lung cancers diagnosed at the same time in the same lung. The study aims to determine whether combining thoracoscopic resection with radiofrequency ablation can preserve more lung function while maintaining acceptable tumor control and safety compared with thoracoscopic resection alone. A total of 160 participants will be randomly assigned in a 1:1 ratio to one of two groups. In the combined-treatment group, the main lung lesion will be removed by video-assisted thoracoscopic surgery, and the secondary lesion will be treated with intraoperative computed tomography-guided radiofrequency ablation. In the surgery-alone group, both the main and secondary lesions will be removed by video-assisted thoracoscopic surgery. The primary outcome is the change in forced expiratory volume in one second (FEV1), a standard measure of lung function, from baseline to 6 months after surgery. Other outcomes include local recurrence, treatment-related complications, disease-free and overall survival, length of hospital stay, medical costs, quality of life, patient satisfaction, and the change in postoperative lung volume compared with preoperative lung volume, as quantitatively measured using three-dimensional chest computed tomography reconstruction. Participants will be followed at approximately 1, 3, 6, 12, and 24 months after surgery.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Age 18 to 80 years, inclusive.
* Diagnosis of synchronous ipsilateral multiple primary lung cancer based on imaging and/or biopsy findings and confirmed by a multidisciplinary team.
* The main lesion is considered suitable for video-assisted thoracoscopic lobectomy or sublobar resection, with complete resection anticipated.
* The secondary lesion is considered suitable for both video-assisted thoracoscopic sublobar resection and intraoperative CT-guided radiofrequency ablation.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Preoperative forced expiratory volume in 1 second of at least 50% of the predicted value.
* Ability to understand the study requirements and willingness to provide written informed consent.

Exclusion Criteria:

* Distant metastatic disease or N2 or N3 lymph node involvement.
* Severe cardiac or pulmonary dysfunction that would preclude the planned surgery, anesthesia, or radiofrequency ablation.
* Previous pulmonary surgery.
* Pregnancy or breastfeeding.
* Active bleeding disorder or severe coagulation abnormality.
* Uncontrolled pulmonary infection or active pulmonary tuberculosis.
* The secondary lesion cannot be safely accessed using the intraoperative CT-guided radiofrequency ablation system.
* The secondary lesion is adjacent to a major blood vessel or another critical structure such that radiofrequency ablation is considered unsafe or unsuitable.