R91
Conditions
Interventions
Group 1: Group A: after PPL localisation with rEBUS, patients receive 6x rEBUS-TBFB with the lock left in place
Group 2: Group B: after PPL localisation with rEBUS, patients receive 6x rEBUS-TBCB with
Sponsors
Städtisches Klinikum Braunschweig gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: - Patient with peripheral lung lesion(s) =1cm in size requiring evaluation - Patient is a candidate for an elective rEBUS TBCB and rEBUS TBFB procedure in the opinion of the treating physician
Exclusion criteria
Exclusion criteria: -The patient is unable or unwilling to participate in this study -The patient has participated in a research study on a drug or device that would interfere with this study within 30 days prior to enrollment in the study -Female patients who are pregnant or breastfeeding -The patient has contraindications to general anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3.1 Primary endpoint: Diagnostic accuracy of rEBUS-TBCB as compared with rEBUS-TBFB. (including enough material for molecular diagnostic testing if needed). Diagnostic accuracy will be calculated as the accuracy of the rEBUS-TBCB vs. rEBUS-TBFB aided diagnosis (based on final pathology results) compared to the final diagnosis made by the tumor board based on all available procedures (surgical lung biopsy, percutaneous needle biopsy, endoscopic biopsy) and follow-up (within 3 months). An rEBUS-TBCB or rEBUS-TBFB will reach the primary endpoint if it provides final diagnosis including sufficient amount of material for molecular diagnostic testing, if needed. Diagnostic accuracy will be calculated as the rate of true positives plus true negatives out of all subjects with attempted lung lesion biopsies. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Diagnostic yield The diagnostic yield of the rEBUS-TBCB procedure compared to the rEBUS-TBFB procedure is calculated on the basis of all subjects for whom a diagnostic biopsy is attempted and is defined as the proportion of subjects for whom the procedure resulted in a definitive diagnosis. 2) Diagnostic accuracy and diagnostic yield as a function of a. Size of the lesion b. Positive bronchus sign c. Anatomical position (lobe, side, distance to the main bronchus) 3) Tissue adequacy Tissue adequacy is defined as the proportion of cases in which the tissue obtained during the ENB index procedure is suitable for subtyping the lung cancer and, if necessary, for molecular testing. 4) Occurrence of periprocedural complications a.) Bronchopulmonary bleeding b.) Pneumothorax c.) Respiratory Failure | — |
Countries
Germany
Contacts
Public ContactThomas Bitter
Städtisches Klinikum Braunschweig gGmbH
Outcome results
None listed