Novel Thin Bronchoscope Versus Ultrathin Bronchoscope for the Diagnosis of Peripheral Pulmonary Nodules

This is a prospective, randomised, non-inferior, multicenter study in consecutive patients with solid or sub-solid PPLs 8 to 30 mm in diameter.The subjects will be randomly assigned in a 1:1:1 ratio to the 3.0mm outer diameter/1.7mm forceps channel ultrathin bronchoscope group (UTB-VBN-EBUS group), the 3.3mm outer diameter/2.0mm forceps channel novel thin bronchoscope combined with guide sheath group (TB1-VBN-EBUS-GS group), and the 4.2mm outer diameter/2.8mm forceps channel novel thin bronchoscope combined with guide sheath group (TB2-VBN-EBUS-GS group). All procedures will be performed using UTB or TB with the guidance of virtual bronchoscopic navigation (VBN) combined with radial endobronchial ultrasound (rEBUS), but without fluoroscopy. A small forceps will be used in UTB-VBN-EBUS group and TB1-VBN-EBUS-GS group, while a standard forceps will be used in TB2-VBN-EBUS-GS group. Primary endpoint is the diagnostic yield.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Patients older than 18 years old.
* Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) that need to be confirmed by pathology. The length diameter of the lesion is no less than 8 mm and no more than 30mm.
* Patients without contraindications of bronchoscopy.
* Patients have good medical adherence and signed informed consent.

Exclusion Criteria:

* Peripheral pulmonary lesion is pure ground-glass opacity.
* Visible lumen lesions in segment and above segment bronchus during bronchoscopy (evidence of endobronchial lesion, extrinsic compression, submucosal tumor, narrowing, inflammation or bleeding of the bronchus).
* The target lesion has been treated.
* Diffuse pulmonary lesions.
* The investigators believe that patient has other conditions that are not suitable for the study.

• BACKGROUNDAsano F, Shinagawa N, Ishida T, Shindoh J, Anzai M, Tsuzuku A, Oizumi S, Morita S. Virtual bronchoscopic navigation combined with ultrathin bronchoscopy. A randomized clinical trial. Am J Respir Crit Care Med. 2013 Aug 1;188(3):327-33. doi: 10.1164/rccm.201211-2104OC. PMID 23600452
• BACKGROUNDOki 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 26039792
• BACKGROUNDOki M, Saka H, Asano F, Kitagawa C, Kogure Y, Tsuzuku A, Ando M. Use of an Ultrathin vs Thin Bronchoscope for Peripheral Pulmonary Lesions: A Randomized Trial. Chest. 2019 Nov;156(5):954-964. doi: 10.1016/j.chest.2019.06.038. Epub 2019 Jul 26. PMID 31356810
• BACKGROUNDAsano F, Ishida T, Shinagawa N, Sukoh N, Anzai M, Kanazawa K, Tsuzuku A, Morita S. Virtual bronchoscopic navigation without X-ray fluoroscopy to diagnose peripheral pulmonary lesions: a randomized trial. BMC Pulm Med. 2017 Dec 11;17(1):184. doi: 10.1186/s12890-017-0531-2. PMID 29228929
• BACKGROUNDYoshikawa M, Sukoh N, Yamazaki K, Kanazawa K, Fukumoto S, Harada M, Kikuchi E, Munakata M, Nishimura M, Isobe H. Diagnostic value of endobronchial ultrasonography with a guide sheath for peripheral pulmonary lesions without X-ray fluoroscopy. Chest. 2007 Jun;131(6):1788-93. doi: 10.1378/chest.06-2506. PMID 17565021
• BACKGROUNDSteinfort DP, Khor YH, Manser RL, Irving LB. Radial probe endobronchial ultrasound for the diagnosis of peripheral lung cancer: systematic review and meta-analysis. Eur Respir J. 2011 Apr;37(4):902-10. doi: 10.1183/09031936.00075310. Epub 2010 Aug 6. PMID 20693253
• BACKGROUNDKurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. doi: 10.1378/chest.126.3.959.