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

NCT07135297 | Not Yet Recruiting

• 1 other identifier: IS25002
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Lung Cancer (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary nodules

  up to 6 months

Secondary Outcomes (6)

• Total examination time

  During the procedure

• Duration of finding lesions

  During the procedure

• Factors affecting the diagnosis yield

  Up to 6 months

• Difference in the bronchus level reached with the bronchoscope

  During the procedure

• Difference in diagnostic yield between the two novel thin bronchoscopes groups

  Up to 6 months

Study Arms (3)

UTB-VBN-EBUS

EXPERIMENTAL

An ultrathin bronchoscope with an outer diameter of 3.0mm and a working channel of 1.7mm will be used in combination with VBN and EBUS. An outer diameter 1.5mm biopsy forceps and a 1.4mm cytology brush will be used for sample collection.

Device: Ultrathin bronchoscope (UTB)

TB1-VBN-EBUS-GS

EXPERIMENTAL

A thin bronchoscope with an outer diameter of 3.3mm and a working channel of 2.0mm will be used in combination with VBN and EBUS. A guide sheath with an outer diameter of 1.95mm, a 1.5mm biopsy forceps, and a 1.4mm cytology brush will be used for sample collection.

Device: Thin bronchoscope (TB1)

TB2-VBN-EBUS-GS

EXPERIMENTAL

A thin bronchoscope with an outer diameter of 4.2mm and a working channel of 2.8mm will be used in combination with VBN and EBUS. A guide sheath with an outer diameter of 2.55mm, a 1.9mm biopsy forceps, and a 1.8mm cytology brush will be used for sample collection.

Device: Thin bronchoscope (TB2)

Interventions

Ultrathin bronchoscope (UTB) DEVICE

A UTB will be used to perform white light bronchoscopy, then the rEBUS probe was inserted into the working channel and advanced to the PPL to obtain a rEBUS view per the navigation path created by VBN workstation. The probe will be withdrawn from the working channel when an optimal rEBUS view obtained. A 1.5-mm biopsy forceps and 1.4-mm cytology brush will be used to collect samples through the working channel.

UTB-VBN-EBUS

Thin bronchoscope (TB1) DEVICE

A thin bronchoscope will be used to perform white light bronchoscopy. A biopsy kit, including a 1.95-mm outer diameter guide sheath, 1.5-mm biopsy forceps, and 1.4-mm cytology brush, will be used to obtain samples with the guidance of VBN.

TB1-VBN-EBUS-GS

Thin bronchoscope (TB2) DEVICE

A thin bronchoscope will be used to perform white light bronchoscopy. A biopsy kit, including a 2.55-mm outer diameter guide sheath, 1.9-mm biopsy forceps, and 1.8-mm cytology brush, will be used to obtain samples with the guidance of VBN.

TB2-VBN-EBUS-GS

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 30mm.
• 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.
• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (5)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315020, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Related Publications (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiayuan Sun

CONTACT

+8618017321598; xkyyjysun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)