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Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694615
First Posted: September 27, 2012
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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 Intervention
Lung Transplantation Procedure: Cryoprobe biopsy Procedure: Forceps Biopsy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 30
Study Start Date: November 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
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
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lonny Yarmus Johns Hopkins University
  More Information

Additional Information:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01694615     History of Changes
Other Study ID Numbers: NA_00052081
First Submitted: September 17, 2012
First Posted: September 27, 2012
Last Update Posted: October 4, 2016
Last Verified: October 2016

Keywords provided by Johns Hopkins University:
Lung Transplantation
Acute Rejection