An Un-blinded, Intra-patient Comparison of Transbronchial Forceps Biopsy and Cryobiopsy for Peripheral Pulmonary Lesions

Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

Sponsors

Lead sponsor: University of Pennsylvania

Collaborator: Andrew Haas
Anil Vachani
Anthony Lanfranco
Kevin Ma
Jeffrey Thompson
Edmund Moon

Source University of Pennsylvania
Brief Summary

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.

Overall Status Terminated
Start Date November 2016
Completion Date March 2, 2020
Primary Completion Date March 2, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule. 1 year
Secondary Outcome
Measure Time Frame
The increase in sensitivity for diagnosing a specific benign lung disease with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule. 1 year
The number of participants with pneumothorax or significant bleeding related to the addition of transbronchial cryobiopsy to standard forceps biopsy. 1 year
Enrollment 31
Condition
Intervention

Intervention type: Procedure

Intervention name: transbronchial biopsy

Arm group label: Single intervention arm - transbronchial biopsy

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David M DiBardino, MD Principal Investigator University of Pennslyvania
Location
facility University of Pennsylvania
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Pennsylvania

Investigator full name: David DiBardino

Investigator title: Assistant Professor of Clinical Medicine, Section of Interventional Pulmonology and Thoracic Oncology, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Single intervention arm - transbronchial biopsy

Arm group type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov