Comparison of Transbronchial, Cryoprobe and VATS Biopsy For the Diagnosis of Interstitial Lung Disease (ILD)
Completed · Not applicable
Conditions studied: Interstitial Lung Disease
In brief
The objective of this study is to compare the sample size, architectural preservation and diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) to bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted Thoracoscopic Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease (ILD).
Key facts
- Study ID
- NCT01972685
- Run by
- Duke University
- People needed
- 14
- Starts
- 2013-06-01
- Expected to finish
- 2018-03-30
- Last updated by the study team
- 2019-07-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject provides informed consent
- Subject is >18 years of age
- Subject is scheduled to undergo VATS biopsy for suspected ILD as part of their standard medical care
- A negative pregnancy test in women of child-bearing potential
- Subject is mentally capable of understanding study procedures
You may not qualify if…
- 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
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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