Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04029155
• Other study ID #: UTB2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2022
• Source: Università Politecnica delle Marche
• Contact: Stefano Gasparini, Professor
• Phone: 071-5964352
• Email: s.gasparini[@]univpm.it
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: June 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Lung biopsy
Transbronchial Needle Aspiration performed via a ultra thin bronchoscope

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stefano Gasparini

References & Publications (13)

Gasparini S, Silvestri GA. Usefulness of transbronchial needle aspiration in evaluating patients with lung cancer. Thorax. 2005 Nov;60(11):890-1. — View Citation

Gasparini S, Zuccatosta L, De Nictolis M. Transbronchial needle aspiration of mediastinal lesions. Monaldi Arch Chest Dis. 2000 Feb;55(1):29-32. — View Citation

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. Review. — View Citation

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. — View Citation

Gasparini S. It is time for this 'ROSE' to flower. Respiration. 2005 Mar-Apr;72(2):129-31. — View Citation

Haponik EF, Shure D. Underutilization of transbronchial needle aspiration: experiences of current pulmonary fellows. Chest. 1997 Jul;112(1):251-3. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess if sensitivity is similar in both arms	percentage	through study completion, an average of 6 months
Primary	Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm	percentage	through study completion, an average of 6 months
Secondary	Assess if diagnostic yield is higher in the "ultrathin" arm than in the "conventional" arm	percentage	through study completion, an average of 6 months