Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study
Patient and methods:
Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic
confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.
They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.
The number of patients required:
One hundred fifty five patients in each group The investigators assumed that the accuracy of
25 gauge is not inferior to 22 gauge, if the accuracy of 25 gauge is within the 10% of the
accuracy of 22 gauge. (under 5% significant level, 80% power)
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
Kwanghyuck Lee, MD
Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
South Korea: Institutional Review Board