Prospective Comparative Study on Endoscopic Ultrasonography (EUS) - Guided Fine-Needle Aspiration (FNA) Using the 22G Conventional Needles or Procore Needles Without Immediate On-site Cytopathologic Examination
Endoscopic ultrasound (EUS) - guided fine needle aspiration (FNA) is a well-established
technique for tissue sampling of intestinal and extra-intestinal mass lesions. The accuracy
of EUS-guided FNA varies from 60% - 100% with a complication rate of 0% - 3%. The diagnostic
accuracy of the procedure can be improved by the use immunohistochemical studies and genetic
analyses.It may also be improved by obtaining a larger biopsy specimen with a core biopsy
needle. However, puncturing with a core-biopsy needle may not be always feasible due to the
technical difficulty of inserting the larger needle through the bended endoscope. As a
result, the advantage of a core-biopsy needle on providing a larger amount of cellular
material is offset by a higher rate of technical failures, especially in the setting of a
transduodenal puncture. Recently, a new 22G FNA needle with a reverse bevel at the tip has
become available (ECHO-HD-22-C, Cook Endoscopy, USA.). The design of the device promotes the
collection of core samples by shearing material from target lesion during retrograde
movement of the needle in the lesion. Hence, the aim of this study is to compare the
tissue-sampling rate and the diagnostic accuracy rate of EUS-FNA using 22G conventional and
Procore needles.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Proportion of patients with cyto-histopathology confirmed neoplasms diagnosed by EUS-guided FNA
A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
1 year
No
CHARING CHONG, MBChB
Principal Investigator
Department of Surgery, CUHK
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
ChineseUHK
NCT01581762
April 2012
October 2014
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