Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-14

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)

Fluoroscopy + RP-EBUS and consecutive lesion sampling by TBNA and/or TBB

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No