The purpose of this study is to compare the effectiveness of transbronchial biopsy done by a 1.1mm cryoprobe versus the standard 2.0mm forceps.
A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. This device has the potential to gather larger and higher quality tissue samples than the standard method using forceps, and with potentially fewer complications than older, larger versions of the cryoprobe. For this study, patients will be randomized in a 1:1 fashion to transbronchial biopsy using a 1.1 mm cryoprobe versus 2.0 mm forceps, stratified by indication (evaluation of lung transplant allograft, diffuse parenchymal lung disease or pulmonary parenchymal lesion). Blinding of the proceduralist is not possible due to the nature of the procedure. Pathologists interpreting the biopsy samples will be blinded to the biopsy device used. Patients enrolled in this study will have data collected by research staff for up to 30 days after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the standard of care following bronchoscopic biopsy procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
500
ERBE 1.1mm flexible single-use cryoprobe with oversheath
Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope
Northwestern Medicine
Chicago, Illinois, United States
University of Maryland, Baltimore (UMB)
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis
Diagnostic Yield as Assessed by Number of Patients for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
Time frame: During procedure, up to 1 hour
Histological Accessibility grade of the biopsy specimen
7-point Likert scale: 0-6 with 0 being worse and 6 being best.
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Bleeding Complication Rate
Number of occurrences of bleeding (grade ≥ 3 modified CTCAE).
Time frame: Within 30 days of procedure
Diagnostic yield for pulmonary parenchymal lesions
Diagnostic Yield as Assessed by Number of Patients with pulmonary parenchymal lesions for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
Time frame: During procedure, up to 1 hour
Diagnostic yield for diffuse parenchymal lung disease
Diagnostic Yield as Assessed by Number of Patients with diffuse parenchymal lung disease for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
Time frame: During procedure, up to 1 hour
Diagnostic yield for Lung Transplant
Diagnostic Yield as Assessed by Number of Patients with a Lung Transplant for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
Time frame: During procedure, up to 1 hour
Pneumothorax Complication Rate
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Washington University in Saint Louis (Wash-U)
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, United States
Number of occurrences of pneumothorax requiring chest tube placement (grade ≥ 2, CTCAE).
Time frame: Within 30 days of procedure
Post-Procedure Respiratory Failure Rate
Number of occurrences of post-procedure respiratory failure (defined as the need for non-invasive or mechanical ventilation requiring ICU admission).
Time frame: Within 30 days of procedure
Number of deaths
Number of occurrences of death.
Time frame: Within 30 days of procedure
Total Histologic Area
Total Histologic Area in Square Millimeters.
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Alveolated Area
Alveolated Area Square Millimeters
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Percent Crush Artifact
Percent total area for Crush Artifact.
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Artifact-free lung parenchyma
Percent Artifact-free lung parenchyma.
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Adequacy for Molecular Testing
Assessed as a yes or no using Next Generation Sequencing (NGS).
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Activation Time
Activation Time in Seconds.
Time frame: At the time of procedure, up to 1 hour
Procedure Time
Procedure Time Seconds.
Time frame: At the time of procedure, up to 1 hour