Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

Recruiting now · Not applicable

Conditions studied: Stage IA Lung Cancer

In brief

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.

Key facts

Study ID

NCT06052098

Run by

Hangzhou Broncus Medical Co., Ltd.

People needed

110

Starts

2023-10-11

Expected to finish

2027-10-01

Last updated by the study team

2023-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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