A Study on the Feasibility and Safety of Single-Session Robot-Assisted Bronchoscopy for Diagnosis and Ablation of Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).
详细描述
The increasing detection of peripheral pulmonary lesions (PPLs) necessitates effective, lung-sparing therapies. For inoperable patients, current guidelines dictate a staged workflow involving diagnostic biopsy followed by a separately scheduled ablation. This study aims to evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).
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.
- •Have peripheral pulmonary lesions (PPLs).
- •Meet at least one of the following conditions: (1) Deemed medically inoperable due to surgical intolerance; (2) Have newly developed or residual nodules after previous lung cancer surgery; (3) Present with multiple bilateral pulmonary nodules; or (4) Explicitly refuse surgical resection.
排除标准
- •Centrally located tumors invading the main bronchi.
- •Uncorrectable coagulopathy.
- •Evidence of advanced nodal (N2/N3) or distant metastatic disease (unless the PPL represented an oligometastatic lesion targeted with curative intent).
研究组 & 干预措施
One-stop treatment group
Inoperable patients underwent synchronous biopsy and ablation under RAB and cone-beam CT guidance. Following confirmation of atypical cells by rapid on-site evaluation (ROSE), individualized ablation (cryoablation, radiofrequency ablation, or synergistic irreversible electroporation) was performed in the same anesthetic setting.
干预措施: A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB) (Procedure)
研究者
Jisong Zhang
Doctor of Medicine
Sir Run Run Shaw Hospital