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The use of an ultrathin bronchoscope (UB) has recently been introduced in the diagnosis of peripheral lung lesions. The use of the UB can be supported by navigation systems such as fluoroscopy, ultrasound guidance, electromagnetic navigation, or other technologies, which have complementary potential. Further navigation techniques are still under study. The use of ultrathin instrumentation has already been shown to significantly reduce procedural times compared to traditional instrumentation.
The purpose of the study is to prospectively evaluate the institutional experience of different third-level hospital centers with the use of a UB (MP190F; Olympus Medical Systems, Tokyo, Japan) for sampling peripheral lung lesions by means of transbronchial needle aspiration (TBNA) or transbronchial biopsy (TBB), performed after fluoroscopic navigation and simultaneous radial probe-endobronchial ultrasound (RP-EBUS) assessment.
Design: multicentric, observational study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan) | Device | Fluoroscopy + RP-EBUS and consecutive lesion sampling by TBNA and/or TBB |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the overall diagnostic accuracy | Sensitivity, specificity, positive predictive value, negative predictive value | Within 12 months from the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between the definitive pathological result and the rapid on-site evaluation (R.O.S.E.) | Comparison (% of concordant and % of discordant results) between R.O.S.E. (performed during the procedure by the pulmonologist or by the pathologist) and the final result obtained after the evaluation (by the pathologist) of the samples taken. | Within 15 days from the procedure |
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Inclusion criteria:
Exclusion criteria:
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Sequential screening aimed at recruitment. Enrollment of patients undergoing diagnostic bronchoscopy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto Fantin | Contact | 0432-552550 | alberto.fantin@asufc.sanita.fvg.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti | Not yet recruiting | Ancona | Italy |
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| Evaluation of patient satisfaction at the end of the procedure (Likert scale in relation to the memory of the procedure and the willingness to repeat it in the future.) | Patients will undergo two satisfaction questionnaires, set according to Likert scale, at the end of the endoscopic procedure. | Same day of the procedure |
| Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and diagnostic accuracy | Within 12 months from the procedure |
| Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and patient satisfaction | Correlations will be made between the anesthetic, radiological and procedural parameters with respect to the answers obtained in the satisfaction questionnaires. | Same day of the procedure |
| Pneumologia, Arcispedale S. Maria Nuova | Not yet recruiting | Reggio Emilia | Italy |
|
| Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia | Recruiting | Udine | Italy |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D008171 | Lung Diseases |
| D014397 | Tuberculosis, Pulmonary |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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