Transthoracic vs Transbronchial Radiofrequency Ablation for Lung Cancer

Ablation therapy has been widely used in the treatment of lung cancer and traditionally performed by CT-guided transthoracic puncture. In recent years, with the development of navigational bronchoscopy, exploratory studies on transbronchial ablation for peripheral lung cancer have demonstrated its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term efficacy and safety, as well as its long-term efficacy. This study was designed as a prospective randomised controlled trial with 110 patients expected to participate in the study, randomized in a 1:1 ratio to CT-guided ablation and bronchoscopy-guided ablation treatment groups. The primary study endpoint is the rate of complete ablation at 6 months post-procedure. Secondary study endpoints were success rate of technique implementation, complete ablation rate at 12 months post-procedure, local control rate at 1, 2 and 3 years post-procedure, progression-free survival, overall survival and safety.

Inclusion criteria

• Age greater than 18 years.
• Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary).
• The proposed ablation lesion was evaluated for feasibility of CT and bronchoscopy-guided ablation treatment.
• Consent to initial ablation therapy is given after assessment of unsuitability for surgery or refusal of surgery and signed informed consent form.

Exclusion criteria

• Patients with platelets <50×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term.
• Patients with severe pulmonary fibrosis and pulmonary arterial hypertension.
• Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever >38.5°C.
• Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in the short term.
• Those with poorly controlled malignant pleural effusions.
• Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5~7d before ablation.
• Eastern Cooperative Oncology Group (ECOG) score >2.
• Combination of other tumours with extensive metastases and an expected survival of <6 months.
• Patients with episodic psychosis.
• Patients with implanted electronic devices (e.g. pacemakers or defibrillators).
• Pregnant women, or patients with a pregnancy planned during the study period.
• Have participated or are participating in other clinical studies within the last 30 days.
• Any other condition that the investigator considers inappropriate for participation in this study.