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N/A N=10 Randomized Double-blind Supportive Care

CrYobiopsy With Radial UltraSound Guidance

Pulmonary Disease

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Time to Achieve Hemostasis After Obtaining Cryobiopsy — 146.55; 132.25 seconds — p=0.7878

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Radial Endobronchial Ultrasound Probe (Device); Flouroscopy (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Vanderbilt University Medical Center
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Achieve Hemostasis After Obtaining Cryobiopsy
146.55; 132.25 0.7878
SECONDARY
Grade of Bleeding
9; 12; 8; 7; 2; 1
SECONDARY
Number of Biopsies That Required Additional Interventions to Manage Bleeding
6; 5
SECONDARY
Biopsy Specimen Quality
SECONDARY
Biopsy Size

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 2 liters
  • Hemodynamic instability with systolic blood pressure 120 beats/min, unless deemed to be stable with these values by the attending physicians
  • Patients representing vulnerable populations (prisoners, pregnant women, etc.)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03506295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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