Solitary Pulmonary Nodule, Yield of Cryo Biopsy in Lung Cancer
Conditions
Keywords
solitary pulmonary nodules, transbronchial lung biopsy, endobronchial ultrasound
Brief summary
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions
Detailed description
Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy. Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.
Interventions
PROCEDURECryo biopsy
Cryoprobe, Erbe Company
Sponsors
Heidelberg University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* solitary pulmonary nodule \< 4 cm * no endobronchial lesion * indication for bronchoscopy
Exclusion criteria
* coagulopathy * pulmonary hypertension * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 24 h after intervention | Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 48 h after intervention | Diagnostic yield of the different biopsy techniques in establishing a specific diagnosis of the lesion |
Countries
Germany
Contacts
Primary ContactFelix JF Herth, MD, PhD
Backup ContactRalf Eberhardt, MD
Outcome results
None listed