22G-ProCore vs 22G-Standard Needle in Diagnosis of Lymphadenopathy by EBUS-TBNA
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|ClinicalTrials.gov Identifier: NCT03903471|
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymph Node Disease||Device: 22G-ProCore Endobronchial Ultrasound Needle Device: 22G-Standard Endobronchial Ultrasound Needle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparion of 22G-ProCore and 22G-Standard Needle in Diagnosis of Lymphadenopathy Via EBUS-TBNA: A Prospective, Multicenter, Randomized Controlled Clinical Trial|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: 22G-ProCore Group
The experimental group with 22G-ProCore needle is expected to enroll 300 patients. The 22G-ProCore needle has a 1.5mm long groove 2.5mm above the needle tip, which is expected to have the advantage of taking more biopsy tissues than the 22G-Standard needle.
Device: 22G-ProCore Endobronchial Ultrasound Needle
EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
Active Comparator: 22G-Standard Group
The control group of 22G-Standard needle is expected to include 300 patients, and there is no groove above the needle tip compared with 22G-ProCore needle.
Device: 22G-Standard Endobronchial Ultrasound Needle
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK
- Diagnostic yield of 22G-ProCore needle [ Time Frame: up to 6 months ]Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
- Diagnostic yield of 22G-Standard needle [ Time Frame: up to 6 months ]Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
- The quality of histologic specimen used by 22G-ProCore needle [ Time Frame: up to 6 months ]The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
- The quality of histologic specimen used by 22G-Standard needle [ Time Frame: up to 6 months ]The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
- Diagnostic yield of aspiration techniques [ Time Frame: up to 6 months ]Conventional EBUS-TBNA procedures involve use of 10mL negative suction aspiration techniques. A new aspiration method, the stylet slow-pull technique, involves slow withdrawal of the needle stylet to create minimum negative pressure.
- Diagnostic yield of different agitations [ Time Frame: up to 6 months ]Agitation means needle moving 10 or 20 or 30 times back and forth in lymph nodes per pass.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903471
|Contact: Jiayuan Sun, PhD||+86-021-22200000 ext email@example.com|
|Shanghai Chest Hospital||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Jiayuan Sun, PhD +86-021-22200000 ext 1511 firstname.lastname@example.org|
|Principal Investigator:||Qi Wu||Beijing Cancer Hospital|
|Principal Investigator:||Hao Xu||Second Affiliated Hospital, School of Medicine, Zhejiang University|