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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
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).
Shanghai Chest Hospital
Shanghai, China
RECRUITINGThe difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group
Diagnostic yield is defined as proportion of true positive and true negative.
Time frame: one year
The difference of operation time between ENB-EBUS-GS group and EBUS-GS group
The operation time includes total operation time,total GS time and total EBUS time
Time frame: one week
The difference of complications between ENB-EBUS-GS group and EBUS-GS group
Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation
Time frame: three months
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