Clinical trial NCT05751278: Cryoprobe Versus Forceps for Transbronchial Biopsy
Official title: A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Diseases
Keywords: lung
cryoprobe
bronchoscopic
biopsy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Erbe USA Incorporated
First posted: 2023-03-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis
timeFrame: During procedure, up to 1 hour
Secondary outcomes:
measure: Diagnostic yield for pulmonary parenchymal lesions
timeFrame: During procedure, up to 1 hour
measure: Diagnostic yield for diffuse parenchymal lung disease
timeFrame: During procedure, up to 1 hour
measure: Diagnostic yield for Lung Transplant
timeFrame: During procedure, up to 1 hour
measure: Histological Accessibility grade of the biopsy specimen
timeFrame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
measure: Bleeding Complication Rate
timeFrame: Within 30 days of procedure
measure: Pneumothorax Complication Rate
timeFrame: Within 30 days of procedure
measure: Post-Procedure Respiratory Failure Rate
timeFrame: Within 30 days of procedure
measure: Number of deaths
timeFrame: Within 30 days of procedure
measure: Total Histologic Area
timeFrame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
measure: Alveolated Area
timeFrame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
measure: Percent Crush Artifact
timeFrame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
measure: Artifact-free lung parenchyma
timeFrame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
measure: Adequacy for Molecular Testing
timeFrame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
measure: Activation Time
timeFrame: At the time of procedure, up to 1 hour
measure: Procedure Time
timeFrame: At the time of procedure, up to 1 hour
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center (VUMC)
state: Tennessee
Study officials:
affiliation: Johns Hopkins University
name: Jeffrey Thiboutot, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: