Lung; Node
Conditions
Keywords
Cryobiopsy
Brief summary
Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe
Detailed description
This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.
Interventions
PROCEDUREForceps biopsy and cryobiopsy
Once the nodule is visualized by radial EBUS, the position of the probe in relation to the lesion is noted. Routinely, forceps biopsy and cryobiopsy are used serially in each patient within the same session.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach * 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, communi-cation 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) * Tumors suspicious of endobronchial growth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | up to 1 month | The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Size of malign tissue in millimeter | up to 1 month | The biopsies are assessed for size of malign tissue in milimeter |
| Occurrence of bleeding events | up to 1 month | Occurrence of bleeding events |
| Size of harvested tissue in millimeter | up to 1 month | The biopsies are assessed for total size in millimeter |
| Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent) | 1 day | Lesion orientation with regards of the radial endobronchial ultrasound probe |
| Occurence of pneumothorax | up to 1 month | Detection with X-ray |
| Size of artifact-free alvoelar space in percentage | up to 1 month | Size of artifact-free alvoelar space in percentage |
Countries
Switzerland
Outcome results
None listed