Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients
This study is currently recruiting participants.
Verified September 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Lonny Yarmus, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01694615
First received: September 17, 2012
Last updated: September 26, 2012
Last verified: September 2012
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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 2013 (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
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: | September 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
Lung Transplantation Acute Rejection |
ClinicalTrials.gov processed this record on May 19, 2013