Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of diagnostics obtained with the Archimedes system
研究概览
简要总结
The aim of this study protocol is to evaluate the feasibility of biopsies using the new system called Archimedes® in 12 patients with solitary pulmonary nodules (SPN) suspicious of malignancy not accessible through current bronchoscopy techniques.
详细描述
Due to the improvement of screening techniques, the detection of peripheral and isolated lesions is an increasingly frequent situation. However these SPN cause difficulties in obtaining a sample. Indeed, current endoscopic techniques remain insufficient in terms of performance. Moreover, computed tomography-guided percutaneous needle biopsy despite a very good sensitivity has many limitations related to the size of the lesions, the accessibility and important complications. The Archimedes® system is an improved version of LungPoint® and combines 3D reconstruction of chest images with intraoperative radioscopy. It uses a catheter to access through the bronchial wall the pulmonary parenchyma and navigate to the SPN. All included patients will receive anesthesia consultation, biological assessment and chest CT scan in thin sections. A surgical treatment will always be planned after presentation of the file in a meeting of multidisciplinary consultation of thoracic oncology. The Archimedes® procedure will be performed during a bronchoscopy under general anesthesia. Immediate monitoring consisted in a chest x-ray 1hour after the procedure. Patients' participation in the study will stop once they benefit from their thoracic surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 75 years with a suspicious nodule of malignancy (primary lung tumor or metastasis of another solid tumor whose largest diameter is greater than or equal to 8 mm):
- •Not associated with endobronchial tumor visible during inspection of tracheobronchial tree with soft bronchoscope
- •Located in any part of the lung more than 10mm from the pleura
- •For which surgical management (atypical resection, lobectomy, bilobectomy or pneumonectomy) is planned after presentation of the file at a multidisciplinary consultation meeting on thoracic oncology of the Investigating Hospital Center
- •Patient able to understand the course of the study and giving informed consent
- •Affiliate or beneficiary of a social security scheme
排除标准
- •Threatening cardiac arrhythmias defined by a rhythm disorder dating discovered less than a month ago
- •Myocardial infarction less than one month old
- •Hypercapnic respiratory decompensation less than one month old
- •coagulopathy
- •Thrombocytopenia with platelet count <100,000 / mm3
- •Antecedent (ATCD) of significant bleeding during previous bronchoscopy
- •ATCD of pulmonary arterial hypertension (PAH) or suspicion of PAH defined by a measurement of systolic pulmonary arterial pressure greater than 50 mmHg on echocardiography (this examination is not systematic but the suspicion of PAH on the thoracic CT scan leads to other cardiac echocardiographic examinations or right heart catheterization in case of inconclusive ultrasound)
- •ATCD of pneumonectomy
- •Giant bubble> 5cm located near the nodule or the tunneling path
- •Inability to stop anticoagulant or antiplatelet therapy before the procedure (taking acetylsalicylic acid at any dose is allowed)
- •Pregnant or lactating woman
- •ATCD for thoracic radiotherapy on the nodule side
- •Patient under tutorship or curatorship
结局指标
主要结局
Number of diagnostics obtained with the Archimedes system
时间窗: Month 1
It will be the biopsy yield defined as the number of patients in whom the results of nodule biopsies performed with the Archimedes® system are consistent with the surgical specimen.
次要结局
- Access time to the nodule(Day 21)
- Scheduling time of the procedure(Day 21)
- Fluoroscopy time(Day 21)
- morbi-mortality(Month 1)
- Patient registration time(Day 21)