Sa1437 ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY IS COMPARABLE TO FINE-NEEDLE ASPIRATION IN THE EVALUATION OF PANCREATIC MASSES; AN UPDATED SYSTEMATIC REVIEW AND META-ANALYSIS

Abstract

Background: Since endoscopioc ultrasound-guided fine-needle aspiration (EUS-FNA) has achieved a pivotal role in the diagnostic evaluation of pancreatic masses, recent new dedicated devices to acquire histologic core tissue were introduced. Although a new domestic needle (ClearTip TM , Finemedix, Daegu, South Korea) was developed and has been used in clinical practice, a comparative study to other fineneedle biopsy (FNB) needles was not established. Methods: As a prospective randomized multicenter trial, patients with pancreatic solid lesions who referred for endoscopic ultrasound-guided tissue sampling (EUS-TS) were enrolled. During EUS-TS, each one pass of a new needle (22-gauge ClearTip) and 22G ProCore needle (Cook Medical Inc., Winston-Salem, NC, USA) was randomly performed to obtain a core specimen for same lesions. Technical evaluations such as easy of puncture, visibility of needle in ultrasound image, easy of to-and-fro motion, and angulation of needle after puncture were compared between two needles. To compare the specimen adequacy obtained from each pass of two needles, gross finding for core tissue, arbitrary histologic score, and diagnostic accuracy based on diagnostic standard was evaluated. Results: In total, 103 patients (59 men, 42 women, median age 67 years: range 41-92) were enrolled between July and November 2019. Among them, two patients were excluded due each case of nonpancreatic lesion and loss of follow up. In the technical evaluation, visibility of needle in ultrasound image was statistically better in ClearTip group than ProCore group (99.0% vs. 92.1%, PZ0.035). There were no differences between two groups in terms of presence of gross core tissue (60.4% vs. 55.4%, PZ0.763), histologic class for malignancy (PZ0.497), and microscopic scores (PZ0.665). The overall diagnostic accuracy for malignancy was 86.1% with no difference between two groups (75.2% vs. 69.3%, PZ0.432). Adverse events were occurred in 8 (7.9%) patients including post-puncture bleeding (3), abdominal pain (2), fever (1), and cerebral infarction (1). Conclusions: In our study, ClearTip needle revealed a comparative results to Pro-Core needle in technical assessment and diagnostic performances. Further comparative study is needed for non-pancreatic lesions to validate the efficacy of a new needle.