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Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

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ClinicalTrials.gov Identifier: NCT02983903
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
Andrew Haas
Anil Vachani
Anthony Lanfranco
Kevin Ma
Jeffrey Thompson
Edmund Moon
Information provided by (Responsible Party):
David DiBardino, 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.

Condition or disease Intervention/treatment Phase
Solitary Pulmonary Nodule Multiple Pulmonary Nodules Procedure: transbronchial biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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 : November 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: 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



Primary Outcome Measures :
  1. The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule. [ Time Frame: 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 :
  1. 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. [ Time Frame: 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.

  2. The number of participants with pneumothorax or significant bleeding related to the addition of transbronchial cryobiopsy to standard forceps biopsy. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983903


Contacts
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Contact: David M DiBardino, MD 215-615-0359 david.dibardino@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David M DiBardino, MD    215-615-0359    david.dibardino@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Andrew Haas
Anil Vachani
Anthony Lanfranco
Kevin Ma
Jeffrey Thompson
Edmund Moon
Investigators
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Principal Investigator: David M DiBardino, MD University of Pennslyvania

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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     History of Changes
Other Study ID Numbers: IRB # 825506
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases