NCT02484066

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

Diagnostic Value of Virtual Bronchoscopic Navigation (VBN) Combined With Endobronchial Ultrasound (EBUS) With a Guide Sheath (GS) for Peripheral Pulmonary Lesions (PPLs) Without Fluoroscopy: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Jiayuan Sun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators 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) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a three centers prospective randomized controlled trial.The participating centers are Department of endoscopy , Shanghai chest Hospital, Shanghai JiaoTong University, China. Department of endoscopy, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, China. Department of Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University, China. Patients are divided into two groups, VBN-EBUS-GS-X-ray group and VBN-EBUS-GS group. Each subject will be randomized to each group. The study is expected to enroll 436 patients at 3 centers.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-07-30
• Completion: 2020-12-01
• First posted: 2015-06-29
• Last updated: 2021-06-22

Locations

1 site across 1 country: China