Prospective, Randomised Study Comparing Two Different Methods of Transbronchial Cryobiopsy in the Interstitial Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Diagnostic yield
研究概览
简要总结
Interstitial lung diseases (ILD) are a heterogeneous collection of more than 100 different pulmonary disorders. Surgical lung biopsie in combination with multidisciplinary discussion is recommend in combination to reach a consensus diagnosis when the initial clinical evaluation is inconclusive in the diagnosis of ILD. Cryobiopsy via bronchoscopy is approved for lung biopsies and allows harvesting of large tissue samples of excellent. This technique is not jet standardized. In this prospective randomised study the investigators want to evaluate the diagnostic yield comparing two different techniques of performing transbronchial cryobiopsy. In this study would be compared a shorter freezing time and more number of biopsies vs a longer freezing time and less number of biopsies.
详细描述
Design:
The investigators design a prospective randomised multicenter study to assess the diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia by comparing two different interventional methods.
Patients with suspected ILD in which the clinical, radiological and BAL-data are insufficient to establish a definitive clinical diagnosis, requiring then tissue specimen to determine a diagnosis would be included.
Therefore this all patients will undergo transbronchial cryobiopsy. If a definitive diagnosis even after cryobiopsy and MDD cannot be made, SLB will be recommended.
For the cryobiopsies the 1.9 mm cryoprobe and ERBECRYO®2 with carbon dioxide will be used. All transbronchial cryobiopsies have to be obtained of one or two lobes of the same lung and in at least two different segments. The bronchopulmonary segment for the cryobiopsy will be selected based on the radiological features shown on a high resolution computed tomography (HRCT) of the chest. The areas with exclusively fibrotic changes should be avoided. After having touched the pleura with the cryopobe, the probe is retracted one to two centimetres and then in this position the freezing process will be initiated. The flexible bronchoscope with the inserted cryoprobe will be removed through the rigid bronchoscope after the sample was obtained.
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 (Participant, Investigator)
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
- •Inpatients with suspected ILD based on clinical and radiological features
- •Male or female patients aged ≥18 years
- •Signed the informed consent
- •Clinical indication to performed a lung biopsy in radiologically proven ILD
排除标准
- •Bleeding risk:
- •Known predisposition to bleeding
- •International randomised ratio (INR) >1,5,
- •Elevated partial thromboplastin time (PTT)
- •Platelet count < 80000/ul
- •Patients who required full-dose therapeutic anticoagulation or clopidogrel or other thienopyridines
- •Oxygen saturation < 90% with supported Oxygen 2l/min
- •Severe bullous pulmonary emphysema
- •Severe cardiac disease (angina pectoris, acute myocardial infarction in the last 6 month, acute hearth failure)
结局指标
主要结局
Diagnostic yield
时间窗: 2 years
The investigator will assess the proportion of patients in which a definitive diagnosis is possible after Multi-Disciplinary Discussion
次要结局
- Number of diagnostic samples(2 years)
- Correlation between the suspected clinical diagnosis and the histological diagnosis(2 years)
- Complications(2 years)
- Correlation between between radiological pattern and final diagnosis(2 years)
研究者
Kaid Darwiche
PD Dr. med Kaid Darwiche, Head Department of Interventional Pneumology
University Hospital, Essen