Transthoracic Versus Transbronchial Radiofrequency Ablation for Peripheral Lung Cancer Staging IA: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Complete ablation rate at 6 months post-procedure
研究概览
简要总结
The aim of this study is to investigate the efficacy and safety of transthoracic versus transbronchial ablation in the treatment of early stage peripheral lung cancer.
详细描述
Ablation therapy has been widely used in the treatment of lung cancer and traditionally performed by CT-guided transthoracic puncture. In recent years, with the development of navigational bronchoscopy, exploratory studies on transbronchial ablation for peripheral lung cancer have demonstrated its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term efficacy and safety, as well as its long-term efficacy. This study was designed as a prospective randomised controlled trial with 110 patients expected to participate in the study, randomized in a 1:1 ratio to CT-guided ablation and bronchoscopy-guided ablation treatment groups. The primary study endpoint is the rate of complete ablation at 6 months post-procedure. Secondary study endpoints were success rate of technique implementation, complete ablation rate at 12 months post-procedure, local control rate at 1, 2 and 3 years post-procedure, progression-free survival, overall survival and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years.
- •Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary).
- •The proposed ablation lesion was evaluated for feasibility of CT and bronchoscopy-guided ablation treatment.
- •Consent to initial ablation therapy is given after assessment of unsuitability for surgery or refusal of surgery and signed informed consent form.
排除标准
- •Patients with platelets <50×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term.
- •Patients with severe pulmonary fibrosis and pulmonary arterial hypertension.
- •Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever >38.5°C.
- •Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in the short term.
- •Those with poorly controlled malignant pleural effusions.
- •Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5~7d before ablation.
- •Eastern Cooperative Oncology Group (ECOG) score >
- •Combination of other tumours with extensive metastases and an expected survival of <6 months.
- •Patients with episodic psychosis.
- •Patients with implanted electronic devices (e.g. pacemakers or defibrillators).
- •Pregnant women, or patients with a pregnancy planned during the study period.
- •Have participated or are participating in other clinical studies within the last 30 days.
- •Any other condition that the investigator considers inappropriate for participation in this study.
研究组 & 干预措施
Transthoracic ablation
Transthoracic ablation
干预措施: ablation (Procedure)
Transbronchial ablation
Transbronchial ablation
干预措施: ablation (Procedure)
结局指标
主要结局
Complete ablation rate at 6 months post-procedure
时间窗: Up to 6 months
This refers to the number of lesions completely ablated 6 months after ablative treatment as a proportion of the total number of ablative treated lesions.
次要结局
- Success rate of technique implementation(Immediate postoperative)
- Overall survival(Up to 36 months)
- Complete ablation rate at 12 months post-procedure(Up to 12 months)
- Progression-free survival(Up to 36 months)
- Safety(Up to 6 months)
- Local control rate at 1, 2 and 3 years post-procedure(Up to 36 months)
- Incidence of complications(Up to 6 months)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital