Diagnostic Value of UTB and TB for PPL

NCT04571476 | Completed DMC

• 1 other identifier: SHCHE202002
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Pulmonary Lesion

Keywords

Ultrathin bronchoscope; Thin bronchoscope; Peripheral pulmonary lesion

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions

  Up to 6 months

Secondary Outcomes (6)

• 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

Study Arms (3)

UTB-VBN-EBUS group

EXPERIMENTAL

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.

Procedure: Ultrathin bronchoscope; Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound

TB-VBN-EBUS-GS group

ACTIVE COMPARATOR

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.

Procedure: Thin bronchoscope; Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound; Procedure: Guide sheath

TB-VBN-EBUS-non-GS group

ACTIVE COMPARATOR

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.

Procedure: Thin bronchoscope; Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound

Interventions

Ultrathin bronchoscope PROCEDURE

Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.

Also known as: UTB

UTB-VBN-EBUS group

Thin bronchoscope PROCEDURE

Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.

Also known as: TB

TB-VBN-EBUS-GS group; TB-VBN-EBUS-non-GS group

Virtual bronchoscopic navigation combined with endobronchial ultrasound PROCEDURE

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.

Also known as: VBN-EBUS

TB-VBN-EBUS-GS group; TB-VBN-EBUS-non-GS group; UTB-VBN-EBUS group

Guide sheath PROCEDURE

GS is a cannula with the thinnest outer diameter of 1.95 mm.

Also known as: GS

TB-VBN-EBUS-GS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 5 cm.
• Patients without contraindications of bronchoscopy.
• Patients have good medical adherence and signed informed consent.

You may not qualify if:

• Peripheral pulmonary lesion is pure ground-glass opacity.
• Absence of bronchus leading to or adjacent to the lesion on thin-slice chest CT.
• 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).
• Diffuse pulmonary lesions.
• The investigators believe that patient has other conditions that are not suitable for the study.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• West China Hospital: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (8)

• 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.

  PMID: 15364779 BACKGROUND

• 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.

  PMID: 20693253 BACKGROUND

• 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.

  PMID: 17565021 BACKGROUND

• 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.

  PMID: 29228929 BACKGROUND

• 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.

  PMID: 31356810 BACKGROUND

• 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: 26039792 BACKGROUND

• 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.

  PMID: 23600452 BACKGROUND

• 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.

  PMID: 35693609 DERIVED

Study Officials

• Jiayuan Sun, MD, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: October 1, 2020
• Study Start: March 8, 2021
• Primary Completion: January 7, 2022
• Study Completion: July 31, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)