NCT06921681Recruiting
Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes
Transbronchial EBUS-guided TBNA and Cryobiopsy of Mediastinal Lymph Nodes in Patients Nonsuspicious for Lung Cancer, Using Different Cryoprobe Freezing Times
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 10 Mar 2025
- Start date
- 7 Mar 2025
- Primary completion date
- 1 Apr 2029
- Lead sponsor
- University of Zurich
- Diseases
- Lung cancer
- NCT number
- NCT06921681
What you commit to
- Study type: Interventional
- Planned participants: 136
- From 7 Mar 2025 to the primary completion date, 1 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clopidogrel or other new antiplatelet drugs within 7 days before biopsy (salicylic acid alone allowed)
Lab values
- INR \> 1.5 or Thrombocytes \< 100 G/l
Age
- Age \< 18 and \> 90 years
Other
- 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
- Anticoagulation with NOAC within 48 hours before biopsy
- Pulmonary lesions suspicious of lung carcinoma
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jürgen Hetzel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.