Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging: the RELIANT 2 Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 7
- 主要终点
- The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
研究概览
简要总结
RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.
详细描述
Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. There are several technologies currently available to biopsy these lesions, including electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB). The latter is used clinically with either conventional fluoroscopy or with cone beam computed tomography (CBCT) guidance, which provides real time 3-dimensional images during the procedure. Recently, CBCT has been integrated with RAB, which allows for automatic update of the lesion location. This update is believed to increase the diagnostic yield of the procedure. Given this new upgrade, we designed this pragmatic, randomized controlled study to test the hypothesis that the diagnostic yield of RAB with integrated CBCT is superior to ENB with integrated digital tomosynthesis in patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Patients undergoing advanced diagnostic bronchoscopy to biopsy a lung lesion will be assigned to either the RAB or ENB based on cluster randomization. Randomization will be revealed each morning before procedures are started. Any advanced diagnostic bronchoscopy scheduled on that day will be performed with the device (RAB or ENB) allocated to that room on that day. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
It is not possible to blind the bronchoscopist or the patient to the platform used for each procedure, as they are both large distinctive-appearing pieces of equipment. However, allocation will be concealed until the morning of the procedure. Thoracic pathologists and bronchoscopy schedulers will remain blinded, thus allocations will not influence scheduling of procedures or histopathological interpretation.
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
- •≥ 18 years of age at time of bronchoscopy
- •Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion
排除标准
- •Patient declines to participate
- •Patients enrolled in another trial which requires the use of one specific navigational platform
结局指标
主要结局
The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
时间窗: 7 days post-procedure
Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified: * Malignancy * Specific benign pathologic findings including: * Organizing pneumonia * Frank purulence/robust neutrophilic inflammation * Granulomatous inflammation * Other specific benign findings such as hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns as adjudicated by an expert lung pathologist.
次要结局
- Duration of bronchoscopy (in minutes)(Duration of procedure, approximately 60 minutes)
研究者
Rafael Paez
Assistant Professor of Medicine
Vanderbilt University Medical Center