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Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

RecruitingNAAges 18 Years - 90 YearsAllUniversity of Zurich
NCT06921681 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information.

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📋 Eligibility rules (as published)
Inclusion Criteria: * At least one mediastinal lesion or hilar 1 cm or longer in the short axis requiring diagnostic bronchoscopy * Age between 18 and 90 years * Written informed consent after participant's information Exclusion Criteria: * Age \< 18 and \> 90 years * Lacking ability to form an informed consent (including impaired judgement, communication barriers) * Contraindication against bronchoscopy (e.g. co-morbidities) * Mediastinal abscess or cyst * Extraordinary blood supply of the lesion visualized by EBUS bronchoscope * INR \> 1.5 or Thrombocytes \< 100 G/l * Clopidogrel or other new antiplatelet drugs within 7 days before biopsy (salicylic acid alone allowed) * Anticoagulation with NOAC within 48 hours before biopsy * Pulmonary lesions suspicious of lung carcinoma
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What it tests

  • Cryobiopsy of lymph nodes group 6 sec
  • Cryobiopsy lymphnode group 3 sec
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Where

1 site
Jürgen Hetzel
Basel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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