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

Jiayuan Sun

Status: Completed

Conditions: Lung Cancer

Treatments: Device: X-ray; Device: VBN; Device: EBUS-GS

Study type: Interventional

Funder types: Other

Identifiers

NCT02484066

SHCHE201503

Details and patient eligibility

About

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.

Full 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.

Enrollment: 436 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

VBN-EBUS-GS group

Experimental group

Description:

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.

Treatment:

Device: EBUS-GS

Device: VBN

VBN-EBUS-GS-X-ray group

Active Comparator group

Description:

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.

Treatment:

Device: EBUS-GS

Device: X-ray

Device: VBN