Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients (Kryo-LUTPL)

University of Zurich (UZH)

Status: Completed

Conditions: Lung Transplant Rejection; Lung Transplant Failure and Rejection

Treatments: Procedure: CB study arm; Procedure: FB-CB study arm

Study type: Interventional

Funder types: Other

Identifiers

NCT05006742

ID 2021-00466

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• routinely performed surveillance bronchoscopy and when indicated including serial FB and CB in the same session in patients wo had undergone lung transplant
• male or female subject of at least 18 years of age
• written informed consent after participant's information signed by patient

Exclusion criteria

• age < 18 years
• Lacking ability to form an informed consent (including impaired judgement, communication barriers)
• Contraindication against bronchoscopy (e.g. co-morbidities)
• INR > 2 or Thrombocytes < 50000
• Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
• Anticoagulation with NOAK within 48 hours before biopsy
• Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

CB study arm

Active Comparator group

Description:

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

Treatment:

Procedure: CB study arm

FB-CB study arm

Active Comparator group

Description:

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

Treatment:

Procedure: FB-CB study arm