Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-03-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Solitary Pulmonary Nodule Multiple Pulmonary Nodules

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single intervention arm - transbronchial biopsy

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

Group Type EXPERIMENTAL

transbronchial biopsy

Intervention Type PROCEDURE

Interventions

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transbronchial biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR