Clinical trial NCT05526573: Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
Official title: Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lung; Node
Lung Diseases
Lung TB
Lung Adenocarcinoma
Lung Transplant Rejection
Keywords: NSCLC
Lung nodule
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sequential screening aimed at recruitment. Enrollment of patients undergoing diagnostic bronchoscopy.

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

* Candidate for a diagnostic procedure for a new peripheral lung lesion or re-biopsy;
* Tissue sampling of the peripheral lesion performed only with UB;
* The patient's ability to understand the individual characteristics and consequences of the clinical study;
* Males and females of any ethnicity;
* Subjects who have given their informed consent to use their clinical data for research purposes.

Exclusion criteria:

* Inability to give informed consent or understand its contents;
* Unavailability of tomographic imaging;
* Failure to use RP-EBUS or fluoroscopic guidance during the procedure;
* Failure to use R.O.S.E. by the pulmonologist or pathologist during the procedure;
* Tissue sampling on the same peripheral lesion using an instrument of a different caliber in replacement or in association;
* Any other significant illness or disorder that, in the investigator's opinion, may put the patient at risk due to study participation.

Primary outcomes:
measure: Evaluate the overall diagnostic accuracy
timeFrame: Within 12 months from the procedure
Secondary outcomes:
measure: Agreement between the definitive pathological result and the rapid on-site evaluation (R.O.S.E.)
timeFrame: Within 15 days from the procedure
measure: 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.)
timeFrame: Same day of the procedure
measure: Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and diagnostic accuracy
timeFrame: Within 12 months from the procedure
measure: Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and patient satisfaction
timeFrame: Same day of the procedure
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti
city: Reggio Emilia
country: Italy
facility: Pneumologia, Arcispedale S. Maria Nuova
city: Udine
country: Italy
facility: Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia
Study officials:
References: