Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes
Recruiting · NCT06921681 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Zurich
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Jürgen Hetzel - Basel, Switzerland