Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.

Inclusion criteria

• Age greater than 18 years.
• Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
• The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
• Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.

Exclusion criteria

• Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
• Patients with severe pulmonary fibrosis and pulmonary hypertension.
• Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
• Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
• Patients with poorly controlled malignant pleural effusion.
• Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5~7 days before ablation.
• Eastern Cooperative Oncology Group (ECOG) score > 2.
• Combined with other tumors with extensive metastasis, expected survival < 6 months.
• Patients with episodic psychosis.
• Patients with implantable electronic devices (such as pacemaker or defibrillator).
• Pregnant women, or patients who have pregnancy plans during the study.
• Participation or ongoing participation in another clinical study within the past 30 days.
• Other situations that the investigator deems inappropriate to participate in this study.