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Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

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ClinicalTrials.gov Identifier: NCT02983903
Recruitment Status : Terminated (Interim analysis also showed a lack of benefit in the experimental arm.)
First Posted : December 6, 2016
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
Andrew Haas
Anil Vachani
Anthony Lanfranco
Kevin Ma
Jeffrey Thompson
Edmund Moon
Information provided by (Responsible Party):
David DiBardino, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE December 6, 2016
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions
Official Title  ICMJE An Un-blinded, Intra-patient Comparison of Transbronchial Forceps Biopsy and Cryobiopsy for Peripheral Pulmonary Lesions
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Solitary Pulmonary Nodule
  • Multiple Pulmonary Nodules
Intervention  ICMJE Procedure: transbronchial biopsy
Study Arms  ICMJE 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
Intervention: Procedure: transbronchial biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 23, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2016)
90
Actual Study Completion Date  ICMJE March 2, 2020
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02983903
Other Study ID Numbers  ICMJE IRB # 825506
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David DiBardino, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • Andrew Haas
  • Anil Vachani
  • Anthony Lanfranco
  • Kevin Ma
  • Jeffrey Thompson
  • Edmund Moon
Investigators  ICMJE
Principal Investigator: David M DiBardino, MD University of Pennslyvania
PRS Account University of Pennsylvania
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP