Lung CancerNCT05526573
Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
An observational study of Lung Cancer and Lung; Node, run by Azienda Sanitaria-Universitaria Integrata di Udine at 3 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung; Node, Lung Diseases
- What is being tested?
- Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 3 sitesItaly
- Study dates
- 14 Jul 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sequential screening aimed at recruitment. Enrollment of patients undergoing diagnostic bronchoscopy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Not yet recruiting
Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona
Federico Mei, MD, federico.mei@ospedaliriuniti.marche.it
Stefano Gasparini, MD
- Not yet recruiting
Pneumologia, Arcispedale S. Maria Nuova
Reggio Emilia
Roberto Piro, MD, roberto.piro@ausl.re.it
Nicola Facciolongo, MD
- Recruiting
Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia
Udine
Alberto Fantin, MD, alberto.fantin@asufc.sanita.fvg.it
Vincenzo Patruno, MD
About this study
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
- Being tested
- Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)
- Keywords
- NSCLC, Lung nodule
- Medical subject headings
- Lung Neoplasms, Lung Diseases, Tuberculosis, Pulmonary, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)Device
Fluoroscopy + RP-EBUS and consecutive lesion sampling by TBNA and/or TBB
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the overall diagnostic accuracy
Sensitivity, specificity, positive predictive value, negative predictive value
Measured: 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.)
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.
Measured: 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.
Measured: Same day of the procedure
Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and diagnostic accuracy
Measured: 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.
Measured: Same day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start14 Jul 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fantin, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526573
- Sponsor's protocol ID
- 4393
- Status last verified
- Jan 2024
- First submitted
- 28 Aug 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT05526573
- Acronym / sponsor ID
- 4393
- Conditions
- Lung Cancer, Lung; Node, Lung Diseases, Lung TB, Lung Adenocarcinoma, Lung Transplant Rejection
- Keywords
- NSCLC, Lung nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sequential screening aimed at recruitment. Enrollment of patients undergoing diagnostic bronchoscopy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)Fluoroscopy + RP-EBUS and consecutive lesion sampling by TBNA and/or TBB | Device | – |
Primary outcome
Evaluate the overall diagnostic accuracy
Time frame: Within 12 months from the procedure
Sensitivity, specificity, positive predictive value, negative predictive value
4 secondary outcomes
Agreement between the definitive pathological result and the rapid on-site evaluation (R.O.S.E.)
Time frame: 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.)
Time frame: Same day of the procedure
Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and diagnostic accuracy
Time frame: Within 12 months from the procedure
Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and patient satisfaction
Time frame: Same day of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Lung; Node, run by Azienda Sanitaria-Universitaria Integrata di Udine at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Fantin (0432-552550, alberto.fantin@asufc.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the overall diagnostic accuracy (time frame: Within 12 months from the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.