FROSTBITE-2: Cryoprobe Versus Forceps for Transbronchial Biopsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cryoprobe Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe |
Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651
ERBE 1.1mm flexible single-use cryoprobe with oversheath
|
| Active Comparator: Forceps Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps |
Device: Radial Jaw 4 Pulmonary Biopsy Forceps
Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- Bleeding Complication Rate [Within 30 days of procedure]
Number of occurrences of bleeding (grade ≥ 3 modified CTCAE).
- Pneumothorax Complication Rate [Within 30 days of procedure]
Number of occurrences of pneumothorax requiring chest tube placement (grade ≥ 2, CTCAE).
- 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.
- 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.
- Alveolated Area [Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)]
Alveolated Area Square Millimeters
- 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.
- 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.
- 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).
- Activation Time [At the time of procedure, up to 1 hour]
Activation Time in Seconds.
- Procedure Time [At the time of procedure, up to 1 hour]
Procedure Time Seconds.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or Female, ≥ 18-years-old
-
Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
- Erbe USA Incorporated
Investigators
- Principal Investigator: Jeffrey Thiboutot, MD, MHS, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00344800