A New Guide for Our Guided-Bronchoscopy: The Use of Cone-Beam CT to Enhance Navigation and Diagnostic Yield of RP-EBUS and Hybrid Bronchoscope for Peripheral Lung Nodules Suspicious for Malignancy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography
研究概览
简要总结
This pilot clinical trial studies how well cone-beam computed tomography (CBCT) works in guiding bronchoscopy in patients with lung lesions. CBCT during bronchoscopy may help doctors to biopsy lung lesions that are harder to reach.
详细描述
PRIMARY OBJECTIVES:
I. To describe the feasibility of using CBCT as an additional aid to guided-bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS)/hybrid scope for the diagnosis of peripheral lung nodules.
SECONDARY OBJECTIVES:
I. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS (RP-EBUS-navigation yield) and confirmed with CBCT.
II. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS and samples are diagnostic (diagnostic yield-RP-EBUS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing guided-bronchoscopy for diagnosis of peripheral lung lesion/s > 1 and < 3 cm in diameter located in the outer 2/3 of the lung fields
排除标准
- •Pregnant or breastfeeding women
- •Patient with indications for mediastinal lymph node (LN) sampling per 13th American College of Clinical Pharmacy (ACCP) guidelines
- •Patient with metastatic disease (from primaries other than lung) who have suspicious mediastinal or hilar LN that require sampling
- •Patients with contraindication/s for general anesthesia (e.g., severe and active coronary artery disease, chronic obstructive pulmonary disease [COPD] with forced expiratory volume in 1 second [FEV1] < 1 liter, uncontrolled hypertension, increased intracranial pressure, history of intolerance to general anesthesia)
- •Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study
研究组 & 干预措施
Diagnostic (CBCT)
Patients undergo CBCT during standard of care bronchoscopy.
干预措施: Cone-Beam Computed Tomography (Procedure)
结局指标
主要结局
Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography
时间窗: Up to 6 months
Will be considered feasible if researchers can locate target and bronchoscopic tools with cone-beam computed tomography in at least 80% of the patients (16 out of the 20 participants) that are enrolled.
次要结局
- Proportion of patients with peripheral nodules undergoing bronchoscopy in different subsample(Up to 6 months)
- Localization of the tip with respect to targets(Up to 6 months)
- Diagnostic yield(Up to 6 months)
- Amount of radiation generated by cone-beam computed tomography use(Up to 6 months)
- Fluoroscopy/bronchoscopy time(Up to 6 months)