NCT04029155

Brief 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. Moreover, the ability to identify molecular pattern of lung cancer is essential nowadays, and it will be therefore evaluated.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable lung-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
2.9 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

Same day

First QC Date

July 18, 2019

Last Update Submit

May 25, 2022

Conditions

Lung Cancer

Keywords

peripheral pulmonary nodulesultrathin bronchoscopetransbronchial needle aspiration

Outcome Measures

Primary Outcomes (1)

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

    percentage

    through study completion, an average of 6 months

Secondary Outcomes (1)

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

    through study completion, an average of 6 months

Other Outcomes (1)

  • Assess if sensitivity is similar in both arms

    through study completion, an average of 6 months

Study Arms (2)

TBNA with Conventional bronchoscope

ACTIVE COMPARATOR

patients in this arm will undergo bronchoscopy by a conventional probe

Device: Lung biopsy

TBNA with a Ultrathin bronchoscope

EXPERIMENTAL

Patients in this arm will undergo bronchoscopy by a ultra thin probe

Device: Lung biopsy

Interventions

Lung biopsyDEVICE

Transbronchial Needle Aspiration performed via a ultra thin bronchoscope

TBNA with Conventional bronchoscopeTBNA with a Ultrathin bronchoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 9228384BACKGROUND

  • 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.

    PMID: 10673206BACKGROUND

  • 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.

    PMID: 16263944BACKGROUND

  • 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.

    PMID: 11845850BACKGROUND

  • 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.

    PMID: 18374764BACKGROUND

  • 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.

    PMID: 16541353BACKGROUND

  • 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.

    PMID: 18221551BACKGROUND

  • 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.

    PMID: 27174878BACKGROUND

  • 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.

    PMID: 26039792BACKGROUND

  • 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.

    PMID: 15824520BACKGROUND

  • 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.

    PMID: 10786422BACKGROUND

  • 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.

    PMID: 17641483BACKGROUND

  • 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.

    PMID: 17026811BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Stefano Gasparini, Professor

CONTACT

071-5964352s.gasparini@univpm.it

Martina Bonifazi, Professor

CONTACT

071-5965538m.bonifazi@staff.univpm.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2019

First Posted

July 23, 2019

Study Start

July 1, 2022

Primary Completion

July 1, 2022

Study Completion

June 1, 2023

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share