The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material.
EBUS-TBNA is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. The investigators will explore the performance of two kinds of needles and different methods to obtain tissues via EBUS-TBNA in the study. The study is designed as a prospective, single-center, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22G-ProCore group and the 22G-Standard group. The primary aim is to compare the diagnostic yields of the two types of needles. The secondary endpoint is to assess the quality of histologic specimen. Meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
600
EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDiagnostic yield of 22G-ProCore needle
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Time frame: up to 6 months
Diagnostic yield of 22G-Standard needle
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Time frame: up to 6 months
The quality of histologic specimen used by 22G-ProCore needle
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
Time frame: up to 6 months
The quality of histologic specimen used by 22G-Standard needle
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
Time frame: up to 6 months
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