Lung Cancer
Conditions
Keywords
Endobronchial ultrasonography, Peripheral pulmonary lesions, Ultrathin bronchoscopy
Brief summary
The purpose of this study is to evaluate the feasibility,efficacy and safety of ultrathin bronchoscopy(UTB) combined with virtual bronchoscopic navigation(VBN) and endobronchial ultrasound(EBUS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.
Detailed description
The investigators evaluate feasibility,efficacy and safety of UTB combined with VBN and EBUS for the diagnosis of PPLs without radiographic fluoroscopy.Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The final diagnoses are established by pathological evidence from biopsy or cytology specimen including bronchoscopy or other procedures,microbiological analysis and clinical follow-up.The study is designed as a single center prospective randomized controlled trial.The participating center is Department of endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.Subjects will be randomized (1:1) to UTB-VBN-EBUS-X-ray group and UTB-VBN-EBUS group based on a randomization schedule.The study is expected to enroll 200 patients with 100 patients of each group.
Interventions
PROCEDUREVBN
VBN is carried out by a VBN software（DirectPath;Olympus,Japan) which can automatically create virtual bronchoscopic images.
PROCEDUREEBUS
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.
PROCEDUREX-ray
The radiograph fluoroscopy is performed when the probe is confirmed to reach the lesion by EBUS image ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.
Sponsors
Shanghai Chest Hospital
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
1. Patients with peripheral pulmonary lesions suspected to be cancer that need pathologically confirmed; 2. Presence of bronchus leading to or adjacent to the lesion from CT scan.
Exclusion criteria
1. Pure ground glass opacity (GGO) lesions; 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 UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone | Up to half year | The diagnostic value means diagnostic yields in two groups for benign and malignant lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference of the operation time of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone | Up to half year | The operation time means the total operation time and the total EBUS time. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The difference of complications of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone | Up to half year | Complications mean a composite of operation-related serious adverse events (pneumothorax,bleeding,etc.) during and after the operation in two groups. |
Countries
China
Outcome results
None listed