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Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

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ClinicalTrials.gov Identifier: NCT01694615
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and for surveillance in the diagnosis of acute rejection using standard transbronchial forceps. It is recognized that standard forceps biopsies underestimate the presence or degree of airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been shown in the literature to provide larger samples without crush artifact in a safe fashion in lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is superior to standard transbronchial forceps biopsies in regards to sample size, architecture and the diagnosis of early rejection in lung transplant recipients which if discovered earlier may improve survival.

Condition or disease Intervention/treatment Phase
Lung Transplantation Procedure: Cryoprobe biopsy Procedure: Forceps Biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Controlled Study of Transbronchial Cryoprobe Versus Forceps Biopsy for Acute Rejection in Lung Transplantation
Study Start Date : November 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cryoprobe biopsy
All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared
 Procedure: Cryoprobe biopsy
Active Comparator: Forceps Biopsy
All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared
 Procedure: Forceps Biopsy


Outcome Measures
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Primary Outcome Measures :
  1. Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact) [ Time Frame: From date of study enrollment until the patient is 2 years post lung transplant ]
    Direct measurements of pathologic specimens from the forceps and cryoprobe will be compared. In addition, amount of crush artifact will alse be directly measured and compared utilizing pathology software which measures area of viable tissue.


Secondary Outcome Measures :
  1. Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection) [ Time Frame: From date of study enrollment until the patient is 2 years post lung transplant ]
    Each specimen will be independently reviewed by a lung transplant pathology physician to determine the presence or absence of rejection and results compared. All data will be available to the transplant team in the event any rejection is found, it will be acted upon immediately as per the transplant teams protocol.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals referred for either clinically indicated or surveillance flexible bronchoscopy will be included in the study population
  • Age greater than 18 years and having undergone bilateral orthotopic lung transplantation

Exclusion Criteria:

  • Coagulopathy: plts < 50,000 international normalized ratio (INR) > 1.5
  • Forced expiratory volume at one second (FEV1) < 0.8
  • Diffuse bullous disease
  • Hemodynamic instability
  • Severe hypoxemia
Contacts and Locations
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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): NCT01694615


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Lonny Yarmus Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01694615    
Other Study ID Numbers: NA_00052081
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Keywords provided by Johns Hopkins University:
Lung Transplantation
Acute Rejection