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AzTrials

Lung CancerNCT04029155

Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

A study testing Lung biopsy in people with Lung Cancer, run by Stefano Gasparini.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study's purpose is to evaluate whether the use of an ultra-thin bronchoscope can improve sensitivity and diagnostic yield in peripheral pulmonary nodules. The ultra-thin probe is expected to reach further bronchi and allow to reach peripheral lesions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Lung biopsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
No sites listed yet
Study dates
1 Jul 2022to 1 Jun 2023
Phase
Interventional
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

Who may be able to join

  • age ≥ 18years;
  • presence of at least one peripheral pulmonary lesion ≤ 3 cm on CT scan;
  • ability to give an informed consent.

Who cannot join

  • coagulopathy or bleeding diathesis that cannot be corrected;
  • severe refractory hypoxemia;
  • unstable hemodynamic status;
  • inability to give an informed consent.

Trial locations and contacts

No sites are listed yet.

Stefano Gasparini, Professor contact

071-5964352

s.gasparini@univpm.it

Martina Bonifazi, Professor contact

071-5965538

m.bonifazi@staff.univpm.it

About this study

Official title: Conventional vs Ultrathin Bronchoscopy With Transbronchial Needle Aspiration for the Diagnosis of Peripheral Pulmonary Lesions: a Randomized Controlled Trial

This study's purpose is to evaluate whether the use of an ultra-thin bronchoscope can improve sensitivity and diagnostic yield in peripheral pulmonary nodules. The ultra-thin probe is expected to reach further bronchi and allow to reach peripheral lesions. Moreover, the ability to identify molecular pattern of lung cancer is essential nowadays, and it will be therefore evaluated.

Read the detailed description

142 patients with at least one peripheral pulmonary nodule will be enrolled. They will underwent randomization in 2 arms: patients in the first arm will undergo transbronchial needle aspiration with a conventional bronchoscope patients in the second arm will undergo transbronchial needle aspiration with a ultra-thin bronchoscope. Every bronchoscopy will be performed by the same operator and will contemplate 3 passes for each nodule, followed by Rapid On-Site Evaluation (ROSE) assessed by a dedicated cytologist. If the cytological on-site evaluation is negative in patients in the first arm, they will be shifted to the second arm. Histological and molecular diagnosis will be assessed by a dedicated pathologist. Data will be collected and analyzed.

Conditions
Lung Cancer
Being tested
Lung biopsy
Keywords
peripheral pulmonary nodules, ultrathin bronchoscope, transbronchial needle aspiration
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung biopsyDevice

    Transbronchial Needle Aspiration performed via a ultra thin bronchoscope

Study groups in NCT04029155
Study groupRoleWhat they receive
TBNA with Conventional bronchoscopeActive comparatorpatients in this arm will undergo bronchoscopy by a conventional probe
Receives: Device: Lung biopsy
TBNA with a Ultrathin bronchoscopeExperimentalPatients in this arm will undergo bronchoscopy by a ultra thin probe
Receives: Device: Lung biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm

    percentage

    Measured: through study completion, an average of 6 months

Secondary outcomes (1)

  1. Assess if diagnostic yield is higher in the "ultrathin" arm than in the "conventional" arm

    percentage

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2019
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04029155
Sponsor's protocol ID
UTB2019
Status last verified
May 2022
First submitted
18 Jul 2019
Last updated
26 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haponik EF, Shure D. Underutilization of transbronchial needle aspiration: experiences of current pulmonary fellows. Chest. 1997 Jul;112(1):251-3. doi: 10.1378/chest.112.1.251.

    PubMed 9228384

  • Harrow EM, Abi-Saleh W, Blum J, Harkin T, Gasparini S, Addrizzo-Harris DJ, Arroliga AC, Wight G, Mehta AC. The utility of transbronchial needle aspiration in the staging of bronchogenic carcinoma. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):601-7. doi: 10.1164/ajrccm.161.2.9902040.

    PubMed 10673206

  • Gasparini S, Silvestri GA. Usefulness of transbronchial needle aspiration in evaluating patients with lung cancer. Thorax. 2005 Nov;60(11):890-1. doi: 10.1136/thx.2005.048728. No abstract available.

    PubMed 16263944

  • Patelli M, Lazzari Agli L, Poletti V, Trisolini R, Cancellieri A, Lacava N, Falcone F, Boaron M. Role of fiberscopic transbronchial needle aspiration in the staging of N2 disease due to non-small cell lung cancer. Ann Thorac Surg. 2002 Feb;73(2):407-11. doi: 10.1016/s0003-4975(01)03447-6.

    PubMed 11845850

  • Trisolini R, Tinelli C, Cancellieri A, Paioli D, Alifano M, Boaron M, Patelli M. Transbronchial needle aspiration in sarcoidosis: yield and predictors of a positive aspirate. J Thorac Cardiovasc Surg. 2008 Apr;135(4):837-42. doi: 10.1016/j.jtcvs.2007.11.011.

    PubMed 18374764

  • Iyoda A, Baba M, Shibuya K, Moriya Y, Yasufuku K, Sekine Y, Iizasa T, Hiroshima K, Nakatani Y, Fujisawa T. Transbronchial fine needle aspiration cytological examination: a useful tool for diagnosing primary lung cancer. Thorac Cardiovasc Surg. 2006 Mar;54(2):117-9. doi: 10.1055/s-2005-865924.

    PubMed 16541353

  • Roth K, Hardie JA, Andreassen AH, Leh F, Eagan TM. Predictors of diagnostic yield in bronchoscopy: a retrospective cohort study comparing different combinations of sampling techniques. BMC Pulm Med. 2008 Jan 26;8:2. doi: 10.1186/1471-2466-8-2.

    PubMed 18221551

  • Mondoni M, Sotgiu G, Bonifazi M, Dore S, Parazzini EM, Carlucci P, Gasparini S, Centanni S. Transbronchial needle aspiration in peripheral pulmonary lesions: a systematic review and meta-analysis. Eur Respir J. 2016 Jul;48(1):196-204. doi: 10.1183/13993003.00051-2016. Epub 2016 May 12.

    PubMed 27174878

  • Oki M, Saka H, Ando M, Asano F, Kurimoto N, Morita K, Kitagawa C, Kogure Y, Miyazawa T. Ultrathin Bronchoscopy with Multimodal Devices for Peripheral Pulmonary Lesions. A Randomized Trial. Am J Respir Crit Care Med. 2015 Aug 15;192(4):468-76. doi: 10.1164/rccm.201502-0205OC.

    PubMed 26039792

  • Gasparini S. It is time for this 'ROSE' to flower. Respiration. 2005 Mar-Apr;72(2):129-31. doi: 10.1159/000084041. No abstract available.

    PubMed 15824520

  • Gasparini S, Zuccatosta L, De Nictolis M. Transbronchial needle aspiration of mediastinal lesions. Monaldi Arch Chest Dis. 2000 Feb;55(1):29-32. No abstract available.

    PubMed 10786422

  • Gasparini S. GPS may help drivers reach their destination, but the capability to drive a car is still necessary. Traditional and technology-guided transbronchial needle aspiration. Respiration. 2007;74(4):379-81. doi: 10.1159/000103206. No abstract available.

    PubMed 17641483

  • Gasparini S. Evolving role of interventional pulmonology in the interdisciplinary approach to the staging and management of lung cancer: bronchoscopic mediastinal staging of lung cancer. Clin Lung Cancer. 2006 Sep;8(2):110-5. doi: 10.3816/CLC.2006.n.038.

    PubMed 17026811

Questions about this trial

What is this clinical trial studying?

A study testing Lung biopsy in people with Lung Cancer, run by Stefano Gasparini.

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 3 inclusion and 4 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 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Stefano Gasparini, Professor (071-5964352, s.gasparini@univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04029155, which also lists 13 linked publications.

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 26 May 2022.

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