NCT05257382已完成不适用
A Randomized Controlled Study Evaluating the Added Value of an Hybrid Room Equipped With a Cone Beam CT (CBCT) to Electromagnetic Navigation Bronchoscopy (ENB) for the Diagnosis of Pulmonary Nodule.
Erasme University Hospital2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Diagnostic yield
研究概览
简要总结
A monocentric prospective and randomized trial aiming to compare the diagnostic yield and safety of electromagnetical-guided bronchoscopy (ENB) procedures coupled to trans-bronchial lung cryobiopsies for the diagnosis of pulmonary nodule when performed either in a "standard" bronchoscopy suite or in a hybrid room with CBCT guidance and the use of the CrossCountry technique as required.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary nodule of maximum 30mm of largest diameter
- •Nodules can be either solid or subsolid (including GGO) without evidence of loco-regional or distant metastasis that could be biopsied, and no evidence for an infectious underlying disease.
- •A multidisciplinary discussion is performed for each case before considering its inclusion in the study in order to validate the indication of ENB-guided biopsy. Of note, any other endoscopic or trans-thoracic procedure should be tried before considering ENB if it could achieve the diagnosis according to the investigator's judgment.
排除标准
- •Patient eligible for a direct surgical resection of the nodule
- •Other exclusion criteria are a higher risk of bleeding (platelets count lower than 80,000/mm³, a systolic pulmonary arterial pressure (sPAP) higher than 45 mmHg at transthoracic ultrasonography, prothrombin time international normalized ratio - INR >1.5, activated partial thromboplastin time - APTT >35, uninterrupted anti-coagulant/anti-aggregant therapy), and the presence of any contraindication to general anesthesia as determined by the principal investigator (significant cardiac comorbidities, hypercapnia, severe hypoxia...).
- •No strict limits for inclusion were applied regarding diffusing capacity for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV1).
结局指标
主要结局
Diagnostic yield
时间窗: Through study completion, an average of 1 year
The primary outcome will be the comparison of the diagnostic yield obtained when ENB procedures will be performed on either the "classical " endoscopic suite or in the CBCT suite
次要结局
- Duration of the interventions(Up to one day after the procedure)
- Rate of pneumothorax(up to 1 month after the procedure)
- Rate of bleeding(up to 1 month after the procedure)
研究者
Benjamin Bondue
Chest physician - MD PhD
Erasme University Hospital
研究点 (2)
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