About this trial
The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
- The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Treatment groups
Sponsors and collaborators
Hangzhou Broncus Medical Co., Ltd.
Lead sponsor
Shanghai Chest Hospital
Collaborator