NCT07545057尚未招募不适用
A Feasibility Study on Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules Under Robotic-Assisted Bronchoscopy: A Prospective, Single-Arm, Open-Label Clinical Study：ROBUST Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Technical success rate (at the lesion level)
研究概览
简要总结
This is a prospective, single-arm, open-label clinical study. The primary study objective is to evaluate the feasibility of synchronous biopsy and radiofrequency ablation for pulmonary nodules under robotic-assisted bronchoscopy.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Chest CT indicates pulmonary nodules, highly suspected of being malignant;
- •Size of pulmonary nodules: 8 mm < maximum diameter ≤ 30 mm, and the number of pulmonary nodules requiring intervention ≤ 3;
- •Preoperative imaging evaluation indicates no clear lymph node metastasis or distant metastasis (cT1N0M0);
- •Multidisciplinary evaluation shows that the patient cannot tolerate surgery and radiotherapy, or the patient refuses surgery and radiotherapy after full informed consent;
- •The patient understands and agrees to receive synchronous biopsy and ablation treatment under robotic-assisted bronchoscopy and signs a written informed consent form.
排除标准
- •Patients who cannot tolerate general anesthesia due to advanced age or severe cardiopulmonary diseases, or other reasons;
- •The target nodule has been diagnosed as a malignant tumor or metastasis;
- •Patients with severe bleeding tendency or uncorrectable coagulation disorder (platelet count < 50×10^9 /L, prothrombin time > 18s, prothrombin activity < 40%);
- •Severe pulmonary fibrosis and pulmonary hypertension;
- •Anticoagulant or anti-platelet drugs have not been discontinued for the required time before surgery;
- •Implanted cardiac pacemaker, defibrillator, or other electronic implants;
- •Presence of important blood vessels that cannot be avoided along the biopsy path;
- •Other conditions that the investigators consider not suitable for the patient to participate in this study.
研究组 & 干预措施
Patients with clinically suspected malignant pulmonary nodules requiring diagnosis and treatment
Experimental
干预措施: Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules (Procedure)
结局指标
主要结局
Technical success rate (at the lesion level)
时间窗: 6 months
The proportion of lesions with a definite malignant diagnosis by synchronous biopsy and effective ablation (with postoperative immediate imaging indicating that the ablation range is at least 5 mm larger than the boundary of the target lesion) among the lesions ultimately diagnosed as malignant.
次要结局
- Biopsy diagnostic yield (at the lesion level)(6 months)
- Sensitivity of malignancy (at the lesion level)(6 months)
- Complete ablation rate (at the lesion level)(3 months, 1 year, 2 years, 3 years, and 5 years)
- Local progression-free period (at the lesion level)(3 months, 1 year, 2 years, 3 years, and 5 years)
- Progression-free survival(3 months, 1 year, 2 years, 3 years, and 5 years)
- Overall survival(3 months, 1 year, 2 years, 3 years, and 5 years)
- Pulmonary function indicators (at the patient level)(1 year)
- The incidence of procedure-related complications (at the patient level)(1 month)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital
研究点 (1)
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