Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Broncus Medical Co., Ltd.

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

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hangzhou Broncus Medical Co., Ltd.

Lead sponsor

Shanghai Chest Hospital

Collaborator