Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
研究概览
简要总结
The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease
详细描述
Endoscopic biopsy currently plays only a minor role for the diagnosis of interstitial lung disease. However, in some cases obtaining lung tissue is necessary to establish a final diagnosis. The current standard procedure is transbronchial forceps biopsy - if not sufficient: surgical lung biopsy. Transbronchial lung biopsy bears essential limitations however:
- Small tissue sample
- Limited evaluability of the material caused by forceps-induced crush artifacts
In cryobiopsy the cryoprobe´s tip is being cooled and thereby cools the surrounding tissue to approximately minus 89 degrees Celsius. Subsequently, the frozen probe is retracted with the frozen tissue being attached onto the frozen probe's tip. When applied in the central airways, cryobiopsy proved to deliver large specimens of good quality, which may exceed forceps biopsies in terms of diagnostic yield. Pilot studies on transbronchial cryobiopsy showed that same advantages as seen in the endobronchial use.
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 (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
- •Clinical indications for biopsy of interstitial lung disease
- •Age over 18 years
- •Signed consent
排除标准
- •Risk of bleeding / ongoing anticoagulation
- •Oxygen saturation <90% - despite delivery of 2l oxygen / min
- •Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure)
- •Pulmonary hypertension, PAP sys> 50mmHg
结局指标
主要结局
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
时间窗: 24 months
次要结局
- Differences in the final diagnosis(24 Months)
研究者
Boeckeler, Michael
Dr. med. Michael Böckeler
University Hospital Tuebingen