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

NCT ID: NCT07135297

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-08-31

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.

Detailed Description

This is a prospective, randomised, non-inferior, multicenter study. The inclusion criteria are patients whose chest imaging shows suspiciously malignant peripheral lung nodules (the nodules are surrounded by lung tissue and are located below the segmental bronchus), and the diameter of the lesion is between 8mm and 30mm. 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 were 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 was used in UTB-VBN-EBUS group and TB1-VBN-EBUS-GS group, while a standard forceps was used in TB2-VBN-EBUS-GS group. Primary endpoint is the diagnostic yield. The secondary endpoints include total examination time, the time from bronchoscope insertion of the glottis to the time of removing from the glottis; duration time of finding lesions, the time from insertion of ultrasound probe to withdrawal of ultrasound probe when a rEBUS view was seen; the proportion of lesions visible by rEBUS; factors affecting the diagnostic yield, difference in the bronchus level reached with the bronchoscope; difference in diagnostic yield; and complication rate. Complication rate includes adverse events related to the procedure during or within 1 month after the operation.

Conditions

Lung Cancer (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

UTB-VBN-EBUS

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.

Group Type: EXPERIMENTAL

Ultrathin bronchoscope (UTB)

Intervention Type: 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.

TB1-VBN-EBUS-GS

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.

Group Type: EXPERIMENTAL

Thin bronchoscope (TB1)

Intervention Type: 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.

TB2-VBN-EBUS-GS

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.

Group Type: EXPERIMENTAL

Thin bronchoscope (TB2)

Intervention Type: 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.

Interventions

Ultrathin bronchoscope (UTB)

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.

Intervention Type: DEVICE

Thin bronchoscope (TB1)

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.

Intervention Type: DEVICE

Thin bronchoscope (TB2)

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiayuan Sun

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Shanghai Chest Hospital

Shanghai, , China

Countries

China

Central Contacts

Jiayuan Sun

Role: CONTACT

xkyyjysun@163.com

+8618017321598

Facility Contacts

Jiayuan Sun

Role: primary

xkyyjysun@163.com

+8618017321598

References

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Reference Type: BACKGROUND

PMID: 23600452 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26039792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31356810 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29228929 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17565021 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20693253 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15364779 (View on PubMed)

Other Identifiers

IS25002

Identifier Type: -

Identifier Source: org_study_id