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Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

Primary Purpose

Solitary Pulmonary Nodule, Multiple Pulmonary Nodules

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transbronchial biopsy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Solitary Pulmonary Nodule

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single intervention arm - transbronchial biopsy

Arm Description

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

Outcomes

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.
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.
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.
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.

Full Information

First Posted
November 21, 2016
Last Updated
March 23, 2020
Sponsor
University of Pennsylvania
Collaborators
Andrew Haas, Anil Vachani, Anthony Lanfranco, Kevin Ma, Jeffrey Thompson, Edmund Moon
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1. Study Identification

Unique Protocol Identification Number
NCT02983903
Brief Title
Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions
Official Title
An Un-blinded, Intra-patient Comparison of Transbronchial Forceps Biopsy and Cryobiopsy for Peripheral Pulmonary Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis also showed a lack of benefit in the experimental arm.
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Andrew Haas, Anil Vachani, Anthony Lanfranco, Kevin Ma, Jeffrey Thompson, Edmund Moon

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single intervention arm - transbronchial biopsy
Arm Type
Experimental
Arm Description
Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy
Intervention Type
Procedure
Intervention Name(s)
transbronchial biopsy
Primary Outcome Measure Information:
Title
The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 year
Title
The number of participants with pneumothorax or significant bleeding related to the addition of transbronchial cryobiopsy to standard forceps biopsy.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M DiBardino, MD
Organizational Affiliation
University of Pennslyvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

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