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OpenTrials
Completed

NCT Number: NCT05006742

Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Zurich

Zurich, 8091, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CB study arm

Procedure

Included patients are randomized to receive cryobiopsy

FB-CB study arm

Procedure

Included patients are randomized to receive forceps biopsy and cryobiopsy within the same session

Primary outcomes

  1. diagnostic yield

    Time frame: 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 outcomes

  1. % of patients with treatment alteration due to the biopsy result

    Time frame: up to 1 month

    Impact on treatment decisions depending of the pathology results

  2. Incidence of treatment-emergent adverse events as assessed by pneumothorax rate

    Time frame: up to 1 week

    data on safety

  3. Incidence of treatment-emergent adverse events as assessed by bleeding events

    Time frame: up to 1 week

    data on safety

  4. interobserver agreement between 3 pathologists

    Time frame: up to 3 months

    The biopsies are assessed for acute cellular rejection by three pathologists.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients: A Prospective Analysis for Acute Cellular Rejection

Acronym: Kryo-LUTPL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2021
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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