Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

University of Pennsylvania

Status: Terminated

Conditions: Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Treatments: Procedure: transbronchial biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02983903

IRB # 825506

Details and patient eligibility

About

Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim is to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in patients at risk for lung cancer. Target population: Patients referred for bronchoscopy and lung biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies for their lung lesion during bronchoscopy.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >/= 18
2. At least one peripheral lung lesion >8mm documented on CT scan referred for diagnostic bronchoscopy
3. Subject is able to undergo informed consent

Exclusion criteria

1. Coagulopathy (platelet count < 50,000, INR > 1.5) detected on blood testing done within 6 weeks of the procedural visit
2. Lesion associated with a prominent vessel evident on CT scan
3. Pure ground glass lesion
4. Fibrotic interstitial lung abnormalities on chest CT
5. Bullous emphysema in region of nodule
6. Supplemental oxygen utilization at baseline
7. BMI > 40
8. End stage renal disease

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Single intervention arm - transbronchial biopsy

Experimental group

Description:

Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy

Treatment:

Procedure: transbronchial biopsy