NCT06921681Recruiting
Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes
Summary
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- University of Zurich(Other)
- Protocol no.
- 2024-00885
- Conditions
- Lung Cancer (NSCLC)
- Interventions
- Device
Treatments studied
- Cryobiopsy of lymph nodes group 6 sec
- Cryobiopsy lymphnode group 3 sec
Collaborators
Aarau Cantonal Hospital (KSA), Waid City Hospital, Zurich, Kantonsspital Winterthur KSW, Unispital Basel, Spital Uster AG, Uster, Switzerland, Clinique des Grangettes, Chêne-Bougeries, Insel Gruppe AG, University Hospital Bern, Réseau Hospitalier Neuchâtelois, University of Lausanne Hospitals, Cantonal Hospital of St. Gallen, Ospedale Regionale Bellinzona e Valli, HUG - Hôpitaux universitaires de Genève, Kantonsspital Chur, Switzerland, Hôpital du Valais
Locations · 1
- Basel, SwitzerlandJürgen HetzelRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: April 10, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.