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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Forceps-Cryo 1.1 mm | Active Comparator | Forceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session |
|
| Forceps-Cryo 1.7 mm | Active Comparator | Forceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forceps biopsy and cryobiopsy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage | up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Size of harvested tissue in millimeter | The biopsies are assessed for total size in millimeter | up to 1 month |
| Size of malign tissue in millimeter | The biopsies are assessed for size of malign tissue in milimeter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolin Steinack, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Zurich | Zurich | 8091 | Switzerland |
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| up to 1 month |
| Occurrence of bleeding events | Occurrence of bleeding events | up to 1 month |
| Size of artifact-free alvoelar space in percentage | Size of artifact-free alvoelar space in percentage | up to 1 month |
| Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent) | Lesion orientation with regards of the radial endobronchial ultrasound probe | 1 day |
| Occurence of pneumothorax | Detection with X-ray | up to 1 month |