Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions

NCT05526573 | Unknown

• 1 other identifier: 4393
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

NSCLC; Lung nodule

Outcome Measures

Primary Outcomes (1)

• Evaluate the overall diagnostic accuracy

  Sensitivity, specificity, positive predictive value, negative predictive value

  Within 12 months from the procedure

Secondary Outcomes (4)

• Agreement between the definitive pathological result and the rapid on-site evaluation (R.O.S.E.)

  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.)

  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

  Same day of the procedure

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (3)

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

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases; Tuberculosis, Pulmonary; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Alberto Fantin

CONTACT

0432-552550; alberto.fantin@asufc.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 2, 2022
• Study Start: July 14, 2022
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

IT (3)