Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Lonny Yarmus, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01694615
First received: September 17, 2012
Last updated: March 12, 2014
Last verified: March 2014
  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 cryobiopies 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ACR, chronic rejection, lymphocytic bronchiolitis and infection) [ Time Frame: From date of study enrollment until the patient is 2 years post lung transplant ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 91
Study Start Date: November 2011
Estimated Primary Completion Date: October 2014 (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
none
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 < 50K, INR > 1.5
  • FEV1 < 0.8
  • Diffuse bullous disease
  • Hemodynamic instability
  • Severe hypoxemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694615

Contacts
Contact: Lonny Yarmus lyarmus@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Lonny Yarmus       lyarmus@jhmi.edu   
Principal Investigator: Lonny Yarmus         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lonny Yarmus Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Lonny Yarmus, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01694615     History of Changes
Other Study ID Numbers: NA_00052081
Study First Received: September 17, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Lung Transplantation
Acute Rejection

ClinicalTrials.gov processed this record on July 24, 2014