Kryo-LUTPL: Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: 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: CB study arm
Included patients are randomized to receive cryobiopsy
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Active Comparator: FB-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 forceps biopsy and cryobiopsy within the same session
|
Outcome Measures
Primary Outcome Measures
- diagnostic yield [up to 1 month]
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.
Secondary Outcome Measures
- % of patients with treatment alteration due to the biopsy result [up to 1 month]
Impact on treatment decisions depending of the pathology results
- Incidence of treatment-emergent adverse events as assessed by pneumothorax rate [up to 1 week]
data on safety
- Incidence of treatment-emergent adverse events as assessed by bleeding events [up to 1 week]
data on safety
- interobserver agreement between 3 pathologists [up to 3 months]
The biopsies are assessed for acute cellular rejection by three pathologists.
Eligibility Criteria
Criteria
Inclusion Criteria:
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routinely performed surveillance bronchoscopy and when indicated including serial FB and CB in the same session in patients wo had undergone lung transplant
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male or female subject of at least 18 years of age
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written informed consent after participant's information signed by patient
Exclusion Criteria:
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age < 18 years
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Lacking ability to form an informed consent (including impaired judgement, communication barriers)
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Contraindication against bronchoscopy (e.g. co-morbidities)
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INR > 2 or Thrombocytes < 50000
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Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
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Anticoagulation with NOAK within 48 hours before biopsy
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Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University hospital Zurich | Zurich | Switzerland | 8091 |
Sponsors and Collaborators
- University of Zurich
Investigators
- Principal Investigator: Carolin Steinack, University of Zurich
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID 2021-00466