Bronchoscopic Diagnosis of Peripheral Lung Nodules Using Endobronchial Ultrasound Guided Forceps and Cryobiopsy. A Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe
详细描述
This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach
- •Age between 18 and 90 years
- •Written informed consent after participant's information
排除标准
- •Age < 18 and > 90 years
- •Lacking ability to form an informed consent (including impaired judgement, communi-cation barriers)
- •Contraindication against bronchoscopy (e.g. co-morbidities)
- •INR > 2 or Thrombocytes < 50000
- •Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
- •Anticoagulation with NOAK within 48 hours before biopsy
- •Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg)
- •Tumors suspicious of endobronchial growth
研究组 & 干预措施
Forceps-Cryo 1.1 mm
Forceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session
干预措施: Forceps biopsy and cryobiopsy (Procedure)
Forceps-Cryo 1.7 mm
Forceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session
干预措施: Forceps biopsy and cryobiopsy (Procedure)
结局指标
主要结局
Diagnostic yield
时间窗: up to 1 month
The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage
次要结局
- Size of artifact-free alvoelar space in percentage(up to 1 month)
- Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)(1 day)
- Size of harvested tissue in millimeter(up to 1 month)
- Size of malign tissue in millimeter(up to 1 month)
- Occurrence of bleeding events(up to 1 month)
- Occurence of pneumothorax(up to 1 month)
研究者
Carolin Steinack
Principal Investigator
University of Zurich