NCT06969014招募中不适用
Treatment of Pulmonary Tumors Using Disposable Microwave Ablation Electrodes and a Microwave Ablation System Guided by Bronchoscopy: An Exploratory Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Complete ablation rate of main lesion at 6 months post-procedure
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 ≥18 years old;
- •Pathologically diagnosed as primary peripheral lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer). Or it is a metastatic lung tumor, the primary lesion has been completely resected, and the maximum diameter of the tumor is ≤3cm, the number of tumors requiring intervention is ≤
- •The lesion to be ablated has been evaluated as feasible for microwave ablation treatment under bronchoscopy guidance.
- •Agree to undergo transbronchial MWA as initial treatment after being assessed unsuitable for surgery and radiotherapy or refusing surgery and radiotherapy, and sign informed consent.
排除标准
- •Diffuse lesions in both lungs, for which ablation therapy is ineffective;
- •Preoperative evaluation within one month reveals the presence of intrathoracic lymph node metastasis or extrapulmonary metastasis (excluding cases where extrapulmonary metastasis has been locally controlled);
- •Contraindications to bronchoscopy, or inability to tolerate or comply with bronchoscopic procedures;
- •Severe hemorrhagic tendency, or uncorrectable coagulation disorders (PT > 18 seconds, PTA < 40%);
- •Platelet count < 70 × 10^9/L, or ongoing anticoagulant and/or antiplatelet therapy that has not been discontinued for more than one week prior to ablation (with the exception of prophylactic low-molecular-weight heparin use);
- •Severe pulmonary function impairment, with a maximal ventilatory volume < 40%;
- •Concurrent malignancies with widespread metastasis, with an expected survival of less than three months;
- •Poor overall condition (including widespread metastasis, severe infection, high fever), infectious or radiation-induced inflammation surrounding the lesion, significant cachexia, severe organ dysfunction, severe anemia, or nutritional and metabolic disturbances that cannot be corrected in the short term;
- •Eastern Cooperative Oncology Group (ECOG) performance status score > 2 ;
- •Lesions planned for ablation have received radiotherapy within the past six months;
- •Active hepatitis B, active hepatitis C, known human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive), or other active infections that may impact the patient's ability to undergo treatment as determined by the investigator;
- •History of epilepsy, psychiatric disorders, or cognitive impairments;
- •Patients with implanted cardiac pacemakers;
- •Patients wearing metal jewelry or clothing with metallic components;
- •Pregnant or lactating women, and individuals planning to conceive or become pregnant during the study period;
- •Participation in any other clinical trial within three months prior to signing the informed consent form (non-interventional studies excluded);
- •Any other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
研究组 & 干预措施
Transbronchial microwave ablation
Experimental
干预措施: Microwave ablation (Device)
结局指标
主要结局
Complete ablation rate of main lesion at 6 months post-procedure
时间窗: 6 months
6 months after ablation surgery, the proportion of patients with the main lesion maintained complete ablation among all evaluable patients who received transbronchial microwave ablation treatment.
次要结局
- Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions)(12 months)
- Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients)(12 months)
- Progression-free survival rate at 12 months post-procedure(12 months)
- Overall survival rate at 12 months post-procedure(12 months)
- Local progression-free survival rate at 6,12 months post-procedure(12 months)
- Technical success rate(immediately after transbronchial MWA)
- Safety evaluation of medical device use(immediately after transbronchial MWA)
- ECOG Score(12 months)
研究者
Jiayuan Sun
vice dean of the hospital
Shanghai Chest Hospital
研究点 (1)
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