Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

NCT ID: NCT04029155

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-06-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TBNA with Conventional bronchoscope

patients in this arm will undergo bronchoscopy by a conventional probe

Group Type: ACTIVE_COMPARATOR

Lung biopsy

Intervention Type: DEVICE

Transbronchial Needle Aspiration performed via a ultra thin bronchoscope

TBNA with a Ultrathin bronchoscope

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

Group Type: EXPERIMENTAL

Lung biopsy

Intervention Type: DEVICE

Transbronchial Needle Aspiration performed via a ultra thin bronchoscope

Interventions

Lung biopsy

Transbronchial Needle Aspiration performed via a ultra thin bronchoscope

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stefano Gasparini

OTHER

Sponsor Role: lead

Responsible Party

Stefano Gasparini

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Stefano Gasparini, Professor

Role: CONTACT

s.gasparini@univpm.it

071-5964352

Martina Bonifazi, Professor

Role: CONTACT

m.bonifazi@staff.univpm.it

071-5965538

References

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Reference Type: BACKGROUND

PMID: 9228384 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10673206 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16263944 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 11845850 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 18221551 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27174878 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26039792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15824520 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10786422 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17641483 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17026811 (View on PubMed)

Other Identifiers

UTB2019

Identifier Type: -

Identifier Source: org_study_id