Cryoprobe Versus Forceps for Transbronchial Biopsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy

Conditions
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Lung Diseases

Intervention / Treatment
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* Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651
* Device: Radial Jaw 4 Pulmonary Biopsy Forceps


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoprobe<br>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<br>* ERBE 1.1mm flexible single-use cryoprobe with oversheath<br>|
| Active Comparator: Forceps<br>Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps | Device: Radial Jaw 4 Pulmonary Biopsy Forceps<br>* Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During procedure, up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolated Area | Alveolated Area Square Millimeters | 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. | 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. | 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). | Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) | 
| Activation Time | Activation Time in Seconds. | At the time of procedure, up to 1 hour | 
| Procedure Time | Procedure Time Seconds. | At the time of procedure, up to 1 hour | 
| 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. | 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. | 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. | 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. | 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). | Within 30 days of procedure | 
| Pneumothorax Complication Rate | Number of occurrences of pneumothorax requiring chest tube placement (grade ≥ 2, CTCAE). | 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). | Within 30 days of procedure | 
| Number of deaths | Number of occurrences of death. | Within 30 days of procedure | 
| Total Histologic Area | Total Histologic Area in Square Millimeters. | Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung, cryoprobe, bronchoscopic, biopsy