Interstitial Lung Disease (ILD). Comparative Study of the Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Quality of the tissue sample reported by the pathologist.
研究概览
简要总结
In patients with interstitial lung disease (ILD) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ILD requires a surgical lung biopsy
Transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ILD, typically exceeding 70 -80% .
The aim of this study is to compare and analyze the diagnostic yield, for ILD, and complications following SLB and TC
Methods. The investigators designed a descriptive, comparative and cross-sectional study in patients with ILD, in which SLB and CT will be performed in the same surgical stage, as diagnostic tests.
This study will be conducted from January 2018 to January 2019. Surgical lung biopsy and TC will be performed in the same surgical stage in all patients, under general anesthesia and mechanical ventilation. First TC will be performed by a pulmonologist, sequentially a thoracic surgeon will carry out a SLB.
The samples obtained will be analyzed by different pathologist to compare both techniques in terms of histologic features.
Diagnostic yield, postoperative complications, comorbidities and lenght of stay will be analyzed and compared following these procedures.
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 for suspected ILD eligible for lung biopsy reviewed during multidisciplinary approach.
- •Subject provides informed consent.
- •A negative pregnancy test in women of child-bearing potential.
- •Subject is mentally capable of understanding study procedures.
- •18 years and older.
排除标准
- •Study subject has any disease or condition that interferes with safe completion of the study including:
- •Platelet count < 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) > 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.
- •Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) < 0.8, or radiographically as diffuse bullous disease
- •Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians
- •Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements
- •Concurrent participation in another study involving investigational drugs or investigational medical devices
- •Inability to read and understand the necessary study documents
研究组 & 干预措施
Lung biopsy
Lung biopsy
干预措施: Lung biopsy (Procedure)
结局指标
主要结局
Quality of the tissue sample reported by the pathologist.
时间窗: for statistical analysis, 12 months after the first inclusion
comparison of diagnostic yield of cryobiopsy versus surgical lung biopsy according to the quality of the tissue sample reported by the pathologist.
次要结局
未报告次要终点
研究者
Alejandra Libreros Niño
MD
Hospital Clinic of Barcelona