BACKGROUND: There is a lack of prospective, randomized studies comparing the diagnostic yield and complication rates of 22-gauge and 25-gauge needles during EUS-FNA of solid pancreatic masses. OBJECTIVES: Our primary aim was to compare the diagnostic yield of 22-gauge and 25-gauge needles. Secondary aims included determining the number of needle passes performed, ease of needle passage, and complications. DESIGN: Prospective, randomized study. SETTING:Tertiary referral centers at Yale University School of Medicine, New Haven, Connecticut, and Virginia Piper Cancer Institute, Minneapolis, Minnesota. PATIENTS: Patients with a suspected solid pancreatic mass from February 2007 to June 2008 were enrolled. INTERVENTIONS: Patients were randomized to EUS-FNA with a 22-gauge or 25-gauge needle. MAIN OUTCOME MEASUREMENTS: A diagnostic result was defined as cytology findings positive for malignant cells. RESULTS:A total of 131 patients were enrolled: EUS-FNA was performed with a 22-gauge needle in 64 patients and with a 25-gauge needle in 67 patients. Cytology was diagnostic in 120 (91.6%) of 131 patients overall: 56 (87.5%) of 64 with 22-gauge needles and 64 (95.5%) of 67 with 25-gauge needles (no statistically significant difference was found between the 2 groups; P=.18). A similar number of passes was performed in both arms (mean [SD] 2.6 [1.2] each; P=.96). There were no complications in either group. LIMITATION: A larger number of patients is needed to determine small differences in diagnostic yield. CONCLUSIONS: This is the first prospective, randomized trial comparing 22-gauge and 25-gauge needles in EUS-FNA of solid pancreatic masses. We achieved equally high diagnostic yields by using a similar number of passes, showing that 25-gauge needles are an effective alternative to 22-gauge needles.
RCT Entities:
BACKGROUND: There is a lack of prospective, randomized studies comparing the diagnostic yield and complication rates of 22-gauge and 25-gauge needles during EUS-FNA of solid pancreatic masses. OBJECTIVES: Our primary aim was to compare the diagnostic yield of 22-gauge and 25-gauge needles. Secondary aims included determining the number of needle passes performed, ease of needle passage, and complications. DESIGN: Prospective, randomized study. SETTING: Tertiary referral centers at Yale University School of Medicine, New Haven, Connecticut, and Virginia Piper Cancer Institute, Minneapolis, Minnesota. PATIENTS: Patients with a suspected solid pancreatic mass from February 2007 to June 2008 were enrolled. INTERVENTIONS:Patients were randomized to EUS-FNA with a 22-gauge or 25-gauge needle. MAIN OUTCOME MEASUREMENTS: A diagnostic result was defined as cytology findings positive for malignant cells. RESULTS: A total of 131 patients were enrolled: EUS-FNA was performed with a 22-gauge needle in 64 patients and with a 25-gauge needle in 67 patients. Cytology was diagnostic in 120 (91.6%) of 131 patients overall: 56 (87.5%) of 64 with 22-gauge needles and 64 (95.5%) of 67 with 25-gauge needles (no statistically significant difference was found between the 2 groups; P=.18). A similar number of passes was performed in both arms (mean [SD] 2.6 [1.2] each; P=.96). There were no complications in either group. LIMITATION: A larger number of patients is needed to determine small differences in diagnostic yield. CONCLUSIONS: This is the first prospective, randomized trial comparing 22-gauge and 25-gauge needles in EUS-FNA of solid pancreatic masses. We achieved equally high diagnostic yields by using a similar number of passes, showing that 25-gauge needles are an effective alternative to 22-gauge needles.
Authors: Sachin Wani; Michael B Wallace; Jonathan Cohen; Irving M Pike; Douglas G Adler; Michael L Kochman; John G Lieb; Walter G Park; Maged K Rizk; Mandeep S Sawhney; Nicholas J Shaheen; Jeffrey L Tokar Journal: Am J Gastroenterol Date: 2014-12-02 Impact factor: 10.864
Authors: Christopher J DiMaio; Jonathan M Buscaglia; Seth A Gross; Harry R Aslanian; Adam J Goodman; Sammy Ho; Michelle K Kim; Shireen Pais; Felice Schnoll-Sussman; Amrita Sethi; Uzma D Siddiqui; David H Robbins; Douglas G Adler; Satish Nagula Journal: World J Gastrointest Endosc Date: 2014-10-16