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

NCT07135297 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2025-08-22

No results posted yet for this study

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)

Interventions

DEVICE

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 The probe will be withdrawn from the working channel when an optimal rEBUS view obtained.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.

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.

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.

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07135297 on ClinicalTrials.gov