Multicenter, Prospective, Randomized Trial of Bronchoscopy With Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) With Fluoroscopy for Biopsy of Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 6
- 主要终点
- Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions
研究概览
简要总结
The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs.
This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a solid lung lesion 2-5cm identified on chest CT with the intention to undergo bronchoscopic evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm.The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. This will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment. OR
- •Patients with a solid lung lesion 2-5cm identified on chest CT that are surgical candidates with a high probability of cancer (>65%) will be referred for surgical evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm. If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study. All sites will use the same online calculator to document probability of malignancy.
- •Are at least 22 years old,
- •Lack Bleeding disorders, and
- •Are able to provide informed consent
排除标准
- •Patients with a pure ground-glass opacity identified on chest CT
- •Patients with endobronchial involvement seen on chest CT.
- •Patients who refuse to participate,
- •Are less than 22 years of age,
- •Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, and
- •Are unable to provide informed consent
研究组 & 干预措施
Standard FB with fluoroscopy
Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX).
干预措施: Standard FB with fluoroscopy (Device)
R-EBUS with ultrathin bronchoscope
Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.
Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX.
干预措施: R-EBUS with ultrathin bronchoscope (Device)
结局指标
主要结局
Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Diagnostic yield of standard FB with fluoroscopy using standard adult bronchoscope versus bronchoscopy using ultrathin bronchoscope in combination with R-EBUS with or without Guidesheath for lung lesions 2-5 cm.
次要结局
未报告次要终点