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VBN-EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs

NCT02484066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2021-06-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the feasibility, efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing by using virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

Conditions

Interventions

DEVICE

VBN

VBN is carried out by a VBN software（DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.

DEVICE

EBUS-GS

EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).

DEVICE

X-ray

The radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Jiayuan Sun

    lead OTHER

Principal Investigators

  • Sun Jiayuan, MD · Shanghai Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-07-30
Completion
2020-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT02484066 on ClinicalTrials.gov