Lung Cancer
Conditions
Keywords
Virtual bronchoscopic navigation, Endobronchial ultrasound, Guide Sheath, Transbronchial biopsy, Peripheral pulmonary lesions
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.
Interventions
DEVICEVBN
VBN is carried out by a VBN software（DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.
DEVICEEBUS-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).
DEVICEX-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
Chinese Academy of Medical Sciences
The First Affiliated Hospital of Guangzhou Medical University
Jiayuan Sun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed