Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions

Recruiting

• Conditions: Lung Diseases; Lung; Node; Lung TB; Lung Cancer; Lung Adenocarcinoma; Lung Transplant Rejection

• Registration Number: NCT05526573
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Study First Submitted: 2022-08-28
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the overall diagnostic accuracy	Within 12 months from the procedure	Sensitivity, specificity, positive predictive value, negative predictive value

Secondary Outcome Measures

Name	Time	Method
Agreement between the definitive pathological result and the rapid on-site evaluation (R.O.S.E.)	Within 15 days from the procedure	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.
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.)	Same day of the procedure	Patients will undergo two satisfaction questionnaires, set according to Likert scale, at the end of the endoscopic 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	Same day of the procedure	Correlations will be made between the anesthetic, radiological and procedural parameters with respect to the answers obtained in the satisfaction questionnaires.

Trial Locations

Locations (3)

Pneumologia, Arcispedale S. Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia; 🇮🇹 Udine, Italy

Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti; 🇮🇹 Ancona, Italy