Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

Not Applicable

Recruiting

• Conditions: Stage IA Lung Cancer
• Interventions: Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system; Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system

• Registration Number: NCT06052098
• Lead Sponsor: Hangzhou Broncus Medical Co., Ltd.

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Study Start: 2023-10-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-06
• Primary Completion: 2025-04
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transthoracic group	The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system	Subjects receive CT-guided RFA and undergo follow-up.
Transbronchial group	The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system	Subjects receive bronchoscopy-guided RFA and undergo follow-up.

Primary Outcome Measures

Name	Time	Method
Complete ablation rate at 6 months after ablation	6 months	It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	3 years	It is defined as the total time from the ablation to the death of the subject.
Complete ablation rate 12 months after ablation	12 months	It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.
Progression free survival (PFS)	3 years	It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject.
Technical success rate	Immediately after ablation	It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation.
Safety	12 months	To assess the incidence of device- or procedure-related (serious) adverse events occurring during the study.
Local control rate at 1 year, 2 years and 3 years after ablation	1 year, 2 years and 3years	It is defined as the proportion of lesions with complete ablation and incomplete ablation to all ablated lesions at 1 year, 2 years, and 3 years after ablation.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China