Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Lung Cancer; Lung Adenocarcinoma; Lung Transplant Rejection; Lung; Node; Lung TB
• Intervention / Treatment: Device: Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)

• Study Type: Observational
• Enrollment (Estimated): 148

Contacts and Locations

• Study Contact: Name: Alberto Fantin; Phone Number: 0432-552550; Email: alberto.fantin@asufc.sanita.fvg.it

Study Locations

• Italy
  • Ancona, Italy
    • Not yet recruiting
    • Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti
    • Contact: Federico Mei, MD; Email: federico.mei@ospedaliriuniti.marche.it
    • Principal Investigator: Stefano Gasparini, MD
  • Reggio Emilia, Italy
    • Not yet recruiting
    • Pneumologia, Arcispedale S. Maria Nuova
    • Contact: Roberto Piro, MD; Email: roberto.piro@ausl.re.it
    • Principal Investigator: Nicola Facciolongo, MD
  • Udine, Italy
    • Recruiting
    • Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia
    • Contact: Alberto Fantin, MD; Email: alberto.fantin@asufc.sanita.fvg.it
    • Principal Investigator: Vincenzo Patruno, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Sequential screening aimed at recruitment. Enrollment of patients undergoing diagnostic bronchoscopy.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the overall diagnostic accuracy	Sensitivity, specificity, positive predictive value, negative predictive value	Within 12 months from the procedure

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; Lung nodule
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Lung Diseases; Adenocarcinoma of Lung
• Other Study ID Numbers: 4393

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No