Using ultrathin bronchoscopy to diagnose lung lesions
Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
This study is testing if a new, thinner bronchoscopy method can help doctors better diagnose lung lesions in patients compared to older techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Sanitaria-Universitaria Integrata di Udine Academic / other |
| Locations | 3 sites (Ancona and 2 other locations) |
| Trial ID | NCT05526573 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of ultrathin bronchoscopy (UB) in diagnosing peripheral lung lesions across multiple hospital centers. The approach involves using advanced navigation systems such as fluoroscopy and radial probe-endobronchial ultrasound (RP-EBUS) to assist in tissue sampling through transbronchial needle aspiration (TBNA) or transbronchial biopsy (TBB). The goal is to assess the diagnostic yield and procedural efficiency of UB compared to traditional methods. This multicentric observational study aims to gather data on patient outcomes and procedural success rates.
Who should consider this trial
Good fit: Ideal candidates include individuals with new or previously biopsied peripheral lung lesions who are eligible for diagnostic procedures.
Not a fit: Patients who cannot provide informed consent or have significant comorbidities that may complicate participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and efficient diagnoses of peripheral lung lesions, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results with ultrathin bronchoscopy and navigation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ancona and 2 other locations
- Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti — Ancona, Italy (Not_yet_recruiting)
- Pneumologia, Arcispedale S. Maria Nuova — Reggio Emilia, Italy (Not_yet_recruiting)
- Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia — Udine, Italy (Recruiting)
Study contacts
- Study coordinator: Alberto Fantin
- Email: alberto.fantin@asufc.sanita.fvg.it
- Phone: 0432-552550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.