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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: VBN; Device: EBUS-GS; Device: X-ray

• Registration Number: NCT02484066
• Lead Sponsor: Jiayuan Sun

Brief 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.

Study Timeline

• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-29
• Study Start: 2018-09-01
• Primary Completion: 2019-07-30
• Study Completion: 2020-12-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-19
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

• Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 8mm and non GGO lesions.

Exclusion Criteria

1. Absence of bronchus leading to or adjacent to the lesion from CT scan
2. Refusal of participation
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
4. Presence of concomitant endobronchial lesion during the brochoscopy procerdure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VBN-EBUS-GS group	EBUS-GS	Fluoroscopy are not used in this group. EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.
VBN-EBUS-GS-X-ray group	VBN	EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained with fluoroscopic guidance.
VBN-EBUS-GS group	VBN	Fluoroscopy are not used in this group. EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.
VBN-EBUS-GS-X-ray group	X-ray	EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained with fluoroscopic guidance.
VBN-EBUS-GS-X-ray group	EBUS-GS	EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained with fluoroscopic guidance.

Primary Outcome Measures

Name	Time	Method
The difference of diagnostic value of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB	one year	The diagnostic value means sensitivity and specificity in two groups

Secondary Outcome Measures

Name	Time	Method
The difference of operation time of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB	one year	The operation time includes total operation time,total GS time and total EBUS time
The difference of complications of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB	one year	Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China