Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions

Lung Cancer Clinical Trial

Official title:

Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526573
• Other study ID #: 4393
• Status: Recruiting
• Start date: July 14, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: Alberto Fantin
• Phone: 0432-552550
• Email: alberto.fantin[@]asufc.sanita.fvg.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Lung Cancer
• Lung Diseases
• Lung TB
• Lung Transplant Rejection
• Lung; Node

Intervention

Device:
• Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)
Fluoroscopy + RP-EBUS and consecutive lesion sampling by TBNA and/or TBB

Locations

Country	Name	City	State
Italy	Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti	Ancona
Italy	Pneumologia, Arcispedale S. Maria Nuova	Reggio Emilia
Italy	Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the overall diagnostic accuracy	Sensitivity, specificity, positive predictive value, negative predictive value	Within 12 months from the procedure
Secondary	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
Secondary	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
Secondary	Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and diagnostic accuracy		Within 12 months from the procedure
Secondary	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