Peripheral Pulmonary Nodules
Conditions
Keywords
Electromagnetic navigation bronchoscopy(ENB), peripheral pulmonary nodules, diagnostic yield
Brief summary
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.
Detailed description
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.
Interventions
DEVICEENB
ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
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).
Sponsors
Air Force Military Medical University, China
Xiangya Hospital of Central South University
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 who are older than 18 year-old. 2. Chest CT shows peripheral pulmonary nodule (8mm\<longest diameter≤30mm) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy. 3. Patients who agree to undergo bronchoscopy without any contraindications. 4. Patients who have good compliance and sign informed consent.
Exclusion criteria
1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity. 2. Presence of concomitant endobronchial lesion during the brochoscopy procerdure. 3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group | one year | Diagnostic yield is defined as proportion of true positive and true negative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference of operation time between ENB-EBUS-GS group and EBUS-GS group | one week | The operation time includes total operation time,total GS time and total EBUS time |
| The difference of complications between ENB-EBUS-GS group and EBUS-GS group | three months | Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation |
Countries
China
Contacts
Primary ContactJiayuan Sun, MD,PhD
Outcome results
None listed