CLAD is defined as loss of lung function after other factors, particularly infections have been excluded. Readily accessible diagnostic procedures to detect acute cellular rejection at the earliest possible occasion is crucial for posttransplant survival. Serial lung function tests, laboratory testing and pulmonary imaging are only clinical indicators of chronic allograft dysfunction in lung transplant recipients. Since forceps biopsy to detect acute cellular rejection in lung transplant recipients has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryoprobe.
Eventually, histopathological confirmation is indispensable to establish the diagnosis of acute cellular rejection. The current gold standard for diagnosis and grading of acute cellular rejection in order to initialize the optimal treatment, with particular regard to adjusting immunosuppression, is forceps biopsy to obtain ≥ five samples. Forceps biopsy has a reasonable risk profile in experienced centers and is performed 2, 4, 6 and 12 months posttransplant and when indicated. Given these concerns about diagnostic yield in forceps biopsy and unjustifiable risks after surgical lung biopsy, cryobiopsy has arisen as promising alternative diagnostic procedure. The value of cryobiopsy to obtain a conclusive diagnosis of ACR is discussed controversially due the lack of safety and efficacy data in lung transplant recipients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
Included patients are randomized to receive cryobiopsy
Included patients are randomized to receive forceps biopsy and cryobiopsy within the same session
University hospital Zurich
Zurich, Switzerland
diagnostic yield
To investigate the diagnostic yield of two different transbronchial lung biopsy techniques (forceps and cryobiopsy) for diagnosis of acute cellular rejection in lung transplant recipients.
Time frame: up to 1 month
% of patients with treatment alteration due to the biopsy result
Impact on treatment decisions depending of the pathology results
Time frame: up to 1 month
Incidence of treatment-emergent adverse events as assessed by pneumothorax rate
data on safety
Time frame: up to 1 week
Incidence of treatment-emergent adverse events as assessed by bleeding events
data on safety
Time frame: up to 1 week
interobserver agreement between 3 pathologists
The biopsies are assessed for acute cellular rejection by three pathologists.
Time frame: up to 3 months
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