To hear about similar clinical trials, please enter your email below
Trial Title:
Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
NCT ID:
NCT05526573
Condition:
Lung Cancer
Lung; Node
Lung Diseases
Lung TB
Lung Adenocarcinoma
Lung Transplant Rejection
Conditions: Official terms:
Adenocarcinoma of Lung
Lung Diseases
Conditions: Keywords:
NSCLC
Lung nodule
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)
Description:
Fluoroscopy + RP-EBUS and consecutive lesion sampling by TBNA and/or TBB
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.
Criteria for eligibility:
Study pop:
Sequential screening aimed at recruitment. Enrollment of patients undergoing diagnostic
bronchoscopy.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti
Address:
City:
Ancona
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Federico Mei, MD
Email:
federico.mei@ospedaliriuniti.marche.it
Investigator:
Last name:
Stefano Gasparini, MD
Email:
Principal Investigator
Facility:
Name:
Pneumologia, Arcispedale S. Maria Nuova
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Roberto Piro, MD
Email:
roberto.piro@ausl.re.it
Investigator:
Last name:
Nicola Facciolongo, MD
Email:
Principal Investigator
Facility:
Name:
Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia
Address:
City:
Udine
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alberto Fantin, MD
Email:
alberto.fantin@asufc.sanita.fvg.it
Investigator:
Last name:
Vincenzo Patruno, MD
Email:
Principal Investigator
Start date:
July 14, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Azienda Sanitaria-Universitaria Integrata di Udine
Agency class:
Other
Source:
Azienda Sanitaria-Universitaria Integrata di Udine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05526573
