Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

Broncus Medical

Status: Enrolling

Conditions: Stage IA Lung Cancer

Treatments: Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system; Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06052098

BC-I-RF-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
2. Patients with severe pulmonary fibrosis and pulmonary hypertension.
3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
4. 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.
5. Patients with poorly controlled malignant pleural effusion.
6. 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.
7. Eastern Cooperative Oncology Group (ECOG) score > 2.
8. Combined with other tumors with extensive metastasis, expected survival < 6 months.
9. Patients with episodic psychosis.
10. Patients with implantable electronic devices (such as pacemaker or defibrillator).
11. Pregnant women, or patients who have pregnancy plans during the study.
12. Participation or ongoing participation in another clinical study within the past 30 days.
13. Other situations that the investigator deems inappropriate to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Transbronchial group

Experimental group

Description:

Subjects receive bronchoscopy-guided RFA and undergo follow-up.

Treatment:

Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system

Transthoracic group

Experimental group

Description:

Subjects receive CT-guided RFA and undergo follow-up.

Treatment:

Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system