CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Radial Endobronchial Ultrasound Probe +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03506295
NCT03506295N/ACompleted

CrYobiopsy With Radial UltraSound Guidance (CYRUS)...

Vanderbilt University Medical Center·interventional·Posted Apr 24, 2018·Updated Nov 12, 2019

In Brief

A clinical study evaluating Radial Endobronchial Ultrasound Probe and Flouroscopy for Pulmonary Disease. Completed, enrolled 10 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 24, 2018
Enrollment StartApr 6, 2018
Primary CompletionOct 3, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.2 years ago

Interventions

Radial Endobronchial Ultrasound Probedevice

The radial EBUS procedure is performed by inserting a miniature ultrasound probe (radial EBUS probe) through the working channel of a flexible bronchoscope or catheter (guide sheath). Real-time imaging of the surrounding tissue enables the clinician to determine the lesion's exact location and size.

Flouroscopydevice

Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.