Efficiency Study of the EUS-FNA Needles With and Without a Side Port in Pancreatic Masses
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|ClinicalTrials.gov Identifier: NCT01978808|
Recruitment Status : Unknown
Verified November 2013 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : November 8, 2013
Last Update Posted : November 13, 2013
|Condition or disease|
For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUS-FNA) are well established techniques in clinical practice. In the case of EUS, an ultrasonic transducer located at the tip of the echoendoscope allows the endoscopist to visualize the wall of gastrointestinal tract as a series of definable layers corresponding to histology, and also enables detailed images of areas outside of the digestive tract. EUS has a significant clinical impact because it allows assessment of submucosal GI lesions, loco-regional staging of gastrointestinal malignancy, tissue diagnosis by EUS-FNA and staging of pancreaticobiliary lesions, non-small-cell lung carcinoma, and mediastinal disease. In prospective trials, EUS-FNA has been clearly established to be an important diagnostic tool with excellent safety profile.
Olympus has recently made commercially available a new 22 gauge FNA needle with a side port at the needle tip to facilitate the process of FNA and increase the diagnostic yield. There have been preliminary unpublished retrospective data that suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption. The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield between EZ-Shot 2 (model: NA-220H-8022) and EZ-Shot 2 with side port (NA-230H-8022) in patients with pancreatic masses for evaluation. We hypothesize that a FNA needle with a side port could improve the diagnostic yield.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||A Prospective Multi-center Randomized Study of the Difference in Diagnostic Yield Between EUS-FNA Needles With and Without a Side Port in Pancreatic Masses|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
- the overall diagnostic accuracy rate of both needles [ Time Frame: assessment of diagnostic accuracy rate after 26 wks, then annually later ]
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): NCT01978808
|Contact: Tsu-Yao Cheng||+886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Tsu-Yao Cheng +886-2-23123456 ext 65757 email@example.com|
|Principal Investigator:||Tsu-Yao Cheng||Visiting staff|