CrYobiopsy With Radial UltraSound Guidance
Completed · Not applicable
Conditions studied: Pulmonary Disease
In brief
Transbronchial cryobiopsy carries a higher chance of establishing pathological diagnosis in diffuse parenchymal lung disease (DPLD) than traditional transbronchial forceps guided biopsy. It is a novel technique capable of obtaining large, high-quality samples of lung tissue in a minimally invasive manner. This procedure may decrease the need for surgical lung biopsy in 75% of cases. However, there is an increased risk of pneumothorax and airway bleeding compared to traditional transbronchial forceps guided biopsy. Several strategies are used by practitioners of this technique to mitigate the risks of significant bleeding and pneumothorax. These include prophylactic placement of an endobronchial blocker, the use of fluoroscopy guidance, instillation of cold saline to promote vasoconstriction, and establishment of a secure airway with endotracheal tube placement or rigid bronchoscopy . Vanderbilt University Medical Center is one of the most active centers in terms of cryobiopsies performed as part of the diagnostic workup of DPLD. Currently all transbronchial cryobiopsies here are performed under fluoroscopic guidance, with endotracheal tube intubation and endobronchial blocker placement. Despite these precautions, post biopsy bleeding complications occur and can substantially lengthen the duration of the procedure and occasionally expose patients to procedural complications. Radial ultrasound has been well utilized to define anatomy of peripheral lung and localization of peripheral pulmonary nodules. We postulate that using radial ultrasound to identify peribronchial lung parenchyma with low vascularity will mitigate the risk of hemorrhage during peripheral lung cryobiopsy in patients with DPLD and hence improve patient safety.
Key facts
- Study ID
- NCT03506295
- Run by
- Vanderbilt University Medical Center
- People needed
- 10
- Starts
- 2018-04-06
- Expected to finish
- 2018-10-03
- Last updated by the study team
- 2019-11-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Referral to interventional pulmonary services for diagnostic transbronchial cryobiopsy for diffuse parenchymal lung disease.
- Transbronchial cryobiopsy is determined to be appropriately indicated as determined by consulting interventional pulmonologist.
- Age > 18 years
You may not qualify if…
- Inability to provide informed consent
- Study subject has any condition that interferes with safe completion of the study including:
- Coagulopathy, with criteria left at the discretion of the operator
- Respiratory insufficiency with DLCO < 30% or baseline requirements of oxygen >2 liters
- Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the attending physicians
- Patients representing vulnerable populations (prisoners, pregnant women, etc.)
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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