Tu1635 A Randomized Multicenter Trial Comparing Capillary Suction and Standard Suction for Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Lesions

Tu1635 A Randomized Multicenter Trial Comparing Capillary Suction and Standard Suction for Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Lesions Payal Saxena*, Mohamad H. El Zein, Tyler Stevens, Ahmed Abdelgelil, Sepideh Besharati, Ahmed A. Messallam, Vivek Kumbhari, Alba Azola, Saowanee Ngamruengphong, Jennifer Brainard, Eun Ji Shin, Anne Marie Lennon, Vikesh K. Singh, Mouen Khashab Johns Hopkins, Baltimore, MD; Digestive Disease Institute, Cleveland Clinic, Cleveland, OH; Pathology and Laboratory Medicine, Cleveland Clinic, Cleveland, OH Background: Standard EUS-FNA procedures involve use of no-suction or suction (ST) aspiration techniques. A new aspiration method, the capillary suction technique (CT), involves pulling the needle stylet back slowly to create minimum negative pressure. A prior retrospective study showed higher sensitivity for diagnosis of pancreatic masses using the CT technique. There have been no randomized trials comparing the efficacy of the CT with standard ST Aim: 1) Primary aim was to compare the sensitivity of EUS-FNA using ST or CT for solid pancreatic lesions using a standard 22g needle. 2) Secondary endpoints were first pass diagnostic rate and acquisition of core tissue. Methods: All consecutive patients presenting for EUS-FNA of a solid pancreatic mass at two tertiary academic centers from 9/2013 to 11/2014 were randomized to CT or ST using a 22g needle (Expect, Boston Scientific). CT was performed with an assistant withdrawing 50% of the stylet length. ST was performed with a 10mL suction syringe. Both techniques were standardized to 15 to-and-fro movements for each pass until an adequate specimen was achieved as determined by rapid onsite cytology examination (ROSE). Fanning was performed at the discretion of the endoscopist. Patients were crossed-over to the alternate technique after 4 non-diagnostic passes. All visible core specimens were measured. Positive cytology or surgical histopathology was considered gold standard for malignancy. Negative cytology was confirmed with clinical data and/or imaging at 6 month followup. Results: Of 147 patients screened, 119 (mean age 65yr, 58% male) met inclusion criteria and were randomized to CT (nZ59) or ST (nZ60) (Figure 1). Baseline patient characteristics, including mean mass size, (2.9cm vs 3.2cm, pZ0.22) were similar in both groups. Malignant and benign diagnoses, use of fanning technique, technical success rates (96.6% vs 100%, pZ0.24) and cross-over rates (18.6% vs 18.3%, pZ0.97) were comparable. There were no adverse events. In an intention-totreat analysis, there was no difference in first pass diagnosis rate (40.7% vs 38.3%, pZns) or core specimen acquisition rates (59.3% vs 46.6%, pZns). Mean number of passes to diagnosis (1.9 vs 1.6, pZ 0.22) were equivalent. There was no significant difference in the sensitivity (90 % vs 89%, pZ 1.0), specificity (100% vs 100%, pZ 1.0), or diagnostic accuracy (88.1% vs 85%, pZ0.79) (table 1). Fanning was a not a predictor of diagnostic yield in either group (OR 2.29, pZ0.350 and OR 0.78, pZ0.75). Conclusion: Both capillary suction and standard suction techniques offer high and comparable diagnostic sensitivity of 90% with an average of less than 2 passes required for diagnosis of solid pancreatic lesions. The endosonographer may choose either technique; however, the suction technique may be preferable as coordination with an assistant is not required during FNA.