Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system, The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system.
- Who it may be relevant to
- Registry conditions: Stage IA Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial
Overview
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.
Interventions
- Device The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation. - Device The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.
Primary outcome measures
- Complete ablation rate at 6 months after ablation [Time frame: 6 months]
Secondary outcome measures (6)
- Technical success rate [Time frame: Immediately after ablation]
- Complete ablation rate 12 months after ablation [Time frame: 12 months]
- Local control rate at 1 year, 2 years and 3 years after ablation [Time frame: 1 year, 2 years and 3years]
- Progression free survival (PFS) [Time frame: 3 years]
- Overall survival (OS) [Time frame: 3 years]
- Safety [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT06052098 · BC-I-RF-01