An interventional study of CB study arm and FB-CB study arm in Lung Transplant Rejection and Lung Transplant Failure and Rejection, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by University of Zurich · Not applicable, Interventional, and Diagnostic
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
University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Included patients are 1:1 randomized to receive either CB (CB study arm) or FB and CB within the same session (FB-CB study arm
Procedure: CB study arm
Included patients are 1:1 randomized to receive either CB (CB study arm) or FB and CB within the same session (FB-CB study arm
Procedure: FB-CB study arm
Included patients are randomized to receive cryobiopsy
Included patients are randomized to receive forceps biopsy and cryobiopsy within the same session
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
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Zurich