NCT04571476|CompletedDMC
Diagnostic Value of UTB and TB for PPL
Diagnostic Value of Ultrathin and Thin Bronchoscope for Peripheral Pulmonary Lesions: A Prospective Randomized Controlled Multicenter Study
Loading search results
Diagnostic Value of Ultrathin and Thin Bronchoscope for Peripheral Pulmonary Lesions: A Prospective Randomized Controlled Multicenter Study
Sponsor study identifier
interventional
578
1 country
1
Study Start
March 8, 2021
Actual (reported)Primary Completion
January 7, 2022
Actual (reported)Study Completion
July 31, 2022
Actual (reported)The purpose of the study is to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2020
Actual (reported)October 1, 2020
Actual (reported)March 8, 2021
Actual (reported)January 7, 2022
Actual (reported)July 31, 2022
Actual (reported)Diagnostic yield
Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions
Up to 6 months
Total examination time
During the procedure
Duration of finding lesions
During the procedure
Feature of lesions
Up to 6 months
Difference in the bronchus level reached with the bronchoscope
During the procedure
Difference in diagnostic yield
Up to 6 months
Ultrathin bronchoscope with a 3.0-mm outer diameter and a 1.7-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN and EBUS.
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN-EBUS and a 1.95-mm outer diameter guide sheath.
Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Kurimoto 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.
Steinfort 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.
Jiayuan Sun, MD, PhD
Shanghai Chest Hospital
578 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2020
First Posted
October 1, 2020
Study Start
March 8, 2021
Actual (reported)Diagnosis of Lung Lesions by Endobronchial Ultrasound With an Alternative Guide Sheath
Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using conventional biopsy forceps and cytology brush with the guidance of VBN and EBUS, but without guide sheath.
VBN can create a path to the target lesion automatically when the lesion is depicted in this software.VBN combined with EBUS can improve the diagnostic yield of PPL and shorten the examination time, which has become the standard method for the diagnosis of PPL.
GS is a cannula with the thinnest outer diameter of 1.95 mm.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Yoshikawa 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.
Asano 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.
Oki 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.
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.
Asano 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.
Feng X, Zhang Q, Luo F, Zhang X, Zhang L, Xie F, Sun J, Li S. Study design for a multicenter, randomized controlled trial evaluating the diagnostic value of ultrathin bronchoscope compared to thin bronchoscope without fluoroscopy for peripheral pulmonary lesions. J Thorac Dis. 2022 May;14(5):1663-1673. doi: 10.21037/jtd-22-20.
Primary Completion
January 7, 2022
Actual (reported)Study Completion
July 31, 2022
Actual (reported)Last Updated
September 6, 2023
Record last verified: 2023-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: