Cryoprobe Versus Forceps for Transbronchial Biopsy
- Conditions
- Lung Diseases
- Interventions
- Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651Device: Radial Jaw 4 Pulmonary Biopsy Forceps
- Registration Number
- NCT05751278
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Male or Female, ≥ 18-years-old
- Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care
- Pregnant or nursing woman or woman of child-bearing potential who refuse to take a pregnancy test prior to enrollment
- Severe pulmonary hypertension (RVSP > 60 mmHg)
- Stroke within the last 6 months or myocardial infarction within the last 3 months
- Presence of bleeding disorder
- Platelet count < 50,000 per mL at time of enrollment
- Use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended time prior to invasive procedure (aspirin monotherapy is acceptable)
- Do Not Resuscitate (DNR) status
- Do Not Intubate (DNI) status
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryoprobe ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe Forceps Radial Jaw 4 Pulmonary Biopsy Forceps Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps
- Primary Outcome Measures
Name Time Method Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis During procedure, up to 1 hour Diagnostic Yield as Assessed by Number of Patients for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
- Secondary Outcome Measures
Name Time Method Diagnostic yield for pulmonary parenchymal lesions During procedure, up to 1 hour Diagnostic Yield as Assessed by Number of Patients with pulmonary parenchymal lesions for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
Diagnostic yield for diffuse parenchymal lung disease During procedure, up to 1 hour Diagnostic Yield as Assessed by Number of Patients with diffuse parenchymal lung disease for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
Diagnostic yield for Lung Transplant During procedure, up to 1 hour Diagnostic Yield as Assessed by Number of Patients with a Lung Transplant for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
Histological Accessibility grade of the biopsy specimen Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) 7-point Likert scale: 0-6 with 0 being worse and 6 being best.
Pneumothorax Complication Rate Within 30 days of procedure Number of occurrences of pneumothorax requiring chest tube placement (grade ≥ 2, CTCAE).
Alveolated Area Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) Alveolated Area Square Millimeters
Procedure Time At the time of procedure, up to 1 hour Procedure Time Seconds.
Bleeding Complication Rate Within 30 days of procedure Number of occurrences of bleeding (grade ≥ 3 modified CTCAE).
Adequacy for Molecular Testing Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) Assessed as a yes or no using Next Generation Sequencing (NGS).
Total Histologic Area Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) Total Histologic Area in Square Millimeters.
Artifact-free lung parenchyma Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) Percent Artifact-free lung parenchyma.
Post-Procedure Respiratory Failure Rate Within 30 days of procedure Number of occurrences of post-procedure respiratory failure (defined as the need for non-invasive or mechanical ventilation requiring ICU admission).
Number of deaths Within 30 days of procedure Number of occurrences of death.
Percent Crush Artifact Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) Percent total area for Crush Artifact.
Activation Time At the time of procedure, up to 1 hour Activation Time in Seconds.
Trial Locations
- Locations (7)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
NYU Langone Health
🇺🇸New York, New York, United States
The Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center (VUMC)
🇺🇸Nashville, Tennessee, United States