ACTRN12616001185459已完成不适用
A Prospective Investigation of the Use of the Intuitive Robotic-Assisted Bronchoscope System (Safety and Feasibility Study) in patients with Pulmonary Nodules of Unknown Etiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1) Patients suitable for surgery or intervention, aged 18 years - 75 years
- •2) Pulmonary nodule(s) (PN) due to suspected lung cancer or metastatic disease or nodule(s) of unknown etiology that require further diagnostic evaluation
- •3) One or more soft tissue dominant pulmonary nodules between (and including) 10mm and 30 mm in largest dimension on axial plane
- •4) Nodule completely surrounded by at least 5 mm lung parenchyma, does not touch the hilum or mediastinum, is not associated with adenopathy, atelectasis, or pleural effusion, and the proximal nodule margin (leading edge facing the bronchus & catheter) is more than 1.5 cm distant to the visceral pleura
- •5) Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information using risk prediction algorithms (as described in the review article of Lam and Tammemagi)
- •6) PN accessible bronchoscopically on planning CT reconstruction (within 3 cm proximity to PN)
- •7) Patient able to understand and adhere to study requirements
- •8) Patient able to provide and sign informed consent
- •9) Patient not legally incapacitated
排除标准
- •1) An inability to tolerate bronchoscopy under endotracheal intubation and general anesthesia.
- •2) ASA class greater than or equal to 3
- •3) PN touches the pulmonary hilum or mediastinum, or is associated with adenopathy, lobar atelectasis, or pleural effusion
- •4) Central PN’s located within the first 3 airway generations (segmental airways, B1-10)
- •5) The airway leading to the target lesion arises from an aberrant accessory tracheal bronchus
- •6) Continuous use of anticoagulants (eg, heparin, warfarin) or antiplatelet agents (e.g. Cyclooxygenase Inhibitors (Aspirin), ADP-Receptor inhibitors (Clopidogrel), GP-IIB/IIIA- inhibitors (Abciximac), fish oil, etc) which cannot be discontinued.
- •7) Uncorrectable coagulopathy or bleeding diathesis
- •8) Platelet dysfunction or platelet count less than 100×10 to the 9th power
- •9) History of major bleeding with bronchoscopy
- •10) Pulmonary hypertension with mean Pulmonary Arterial Pressure (PAP) greater than 25 mm
- •11) Moderate-to-severe pulmonary fibrosis
- •12) Severe respiratory insufficiency or hypoxia, moderate-to-severe hypoxemia or any degree of hypercarbia
- •13) One or more bullae greater than 1 cm located in close vicinity (less than 1cm) of target PN
- •14) Giant bullae within the same lobe of the target PN
- •15) Partial tracheal obstruction or obstruction of the superior vena cava
- •16) Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy for example:
- •16a) greater than Stage 3 heart failure (NY-Heart Failure Classification)
- •16b) Unstable hemodynamic status including
- •16c) Uncontrolled dysrhythmias
- •16d) History of ventricular arrhythmias
- •16e) Uncontrolled Hypertension
- •(Blood Pressure systolic greater than 200mmHg, Blood Pressure diastolic greater than 120mmHg)
- •16f) Unstable Angina
- •16g) Myocardial infarction within 6 months
- •16h) Severe cachexia, debility and malnutrition
- •16i) Acute Renal or Liver Failure
- •17) Ongoing systemic acute or chronic infection
- •18) Pneumonia or acute bronchitis within 3 month of the procedure
- •19) Lung abscess
- •20) White Blood Cell (WBC) Count less than 2000 or greater than 20,000
- •21) Recent head injury or increased intracranial pressure
- •22) Contraindication to general anesthesia
- •23) Exposure to radiation treatment or chemotherapy within 3 months prior to the IROB procedure
- •24) Participation in any other study in last 30 days
- •25) Prior thoracic surgery on the same side of the lung as the PN or pneumonectomy of the contralateral lung
- •26) Patients who are pregnant or lactating
- •27) Patients with known intrapulmonary metastases of extrapulmonary cancer/tumors
- •28) Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
- •29) Persons held in an institution by legal or official order, or part of vulnerable population (i.e. mentally disabled)
- •30) Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
研究者
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