Lung Transplantation
Conditions
Keywords
Lung Transplantation, Acute Rejection
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.
Interventions
PROCEDURECryoprobe biopsy
PROCEDUREForceps Biopsy
Sponsors
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact) | 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
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection) | 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. |
Countries
United States
Outcome results
None listed