Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

Sponsor

University of Pennsylvania (Other)

Overall Status

Terminated

CT.gov ID

NCT02983903

Collaborator

Andrew Haas (Other), Anil Vachani (Other), Anthony Lanfranco (Other), Kevin Ma (Other), Jeffrey Thompson (Other), Edmund Moon (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solitary Pulmonary Nodule Multiple Pulmonary Nodules	Procedure: transbronchial biopsy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Mar 2, 2020

Actual Study Completion Date :

Mar 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single intervention arm - transbronchial biopsy Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy	Procedure: transbronchial biopsy

Arm

Intervention/Treatment

Experimental: Single intervention arm - transbronchial biopsy

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

Procedure: transbronchial biopsy

Outcome Measures

Primary Outcome Measures

The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule. [1 year]
Sensitivity for cancer is defined as true positives / (true positives + false negatives) with respect to diagnosing malignancy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of any further, more invasive testing that is clinically indicated to evaluate the nodule.

Secondary Outcome Measures

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]
Sensitivity is defined as true positives / (true positives + false negatives) with respect to diagnosing a specific benign condition that is thought to represent the lung nodule seen on CT scan. If the bronchoscopic procedure fails to diagnose a specific benign condition, the gold standard will be the results of any further, more invasive testing and stable follow-up imaging at 1 year.
The number of participants with pneumothorax or significant bleeding related to the addition of transbronchial cryobiopsy to standard forceps biopsy. [1 year]
A chest X-ray and ultrasound will be done to check for pneumothorax after standard forceps biopsy and after the addition of transbronchial cryobiopsy. Bleeding will be measured with a standardized scale (grade 0 = traces of blood not requiring suctioning; grade 1 = bleeding requiring suction to clear; grade 2 = bleeding requiring wedging of the biopsied segment with the flexible bronchoscope and/or iced saline/epinephrine; grade 3 = bleeding requiring further intervention such as balloon occlusion or inflation of the bronchial blocker; grade 4 = bleeding resulting in airway obstruction and acute hypoxemic respiratory failure, cardiopulmonary instability, transfusion of packed RBCs, and/or admission to the ICU) both after forceps biopsy and again after transbronchial cryobiopsy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania
Andrew Haas
Anil Vachani
Anthony Lanfranco
Kevin Ma
Jeffrey Thompson
Edmund Moon

Investigators

Principal Investigator: David M DiBardino, MD, University of Pennslyvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David DiBardino, Assistant Professor of Clinical Medicine, Section of Interventional Pulmonology and Thoracic Oncology, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT02983903

Other Study ID Numbers:

IRB # 825506

First Posted:

Dec 6, 2016

Last Update Posted:

Mar 25, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Study Results

No Results Posted as of Mar 25, 2020