NCT02464592已完成不适用
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Diagnostic yield of transbronchial lung biopsy (TBLB)
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB).
- •Inform consent signed.
排除标准
- •FEV1 <40% of reference value.
- •Respiratory insufficiency (pO2 <60 mmHg or pCO2 >45 mmHg).
- •Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio > 1.5).
- •Bullous emphysema.
- •Pulmonary arterial hypertension.
- •Hypersensitivity to anaesthetic and sedative drugs (lidocaine, midazolam, propofol, remifentanyl).
- •Psychiatric illness.
- •Comorbidities that could increase the risk of the TBLB.
- •Pregnancy.
研究组 & 干预措施
Biopsy with Cryoprobes
Active Comparator
Transbronchial lung biopsy with a cryoprobe.
干预措施: Transbronchial lung biopsy. (Procedure)
Biopsy with Conventional Forceps
Active Comparator
Transbronchial lung biopsy with conventional forceps.
干预措施: Transbronchial lung biopsy. (Procedure)
结局指标
主要结局
Diagnostic yield of transbronchial lung biopsy (TBLB)
时间窗: 24 months
Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).
次要结局
- Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.(24 months)
- Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.(24 months)
- Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.(24 months)
研究者
研究点 (2)
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