Endoscopic ultrasonography-fine-needle aspiration of solid pancreatic lesions: A prospective, randomized, single-blinded, comparative study using the 22 Gauge EchoTip ® ProCoreTM HD (A) and the 22 Gauge EchoTip ® Ultra HD (B) endoscopic ultrasound needles

Abstract

In order to improve diagnostic efficacy of pancreatic masses, a new endoscopic ultrasonography-fine-needle aspiration (EUS-FNA) needle was developed (EchoTip(®) ProCore™ HD). Very few studies have compared these two needles and none could avoid selection biases.The present study intends to compare the results obtained by these two needles when performing EUS-FNA of pancreatic solid lesions.This was a prospective, single-blinded, randomized, controlled trial conducted at a tertiary care referral center. Thirty consecutive patients with solid pancreatic lesions were enrolled to have EUS-FNA performed with two different types of needle. All patients were punctured with the two needles and were randomized regarding the order of the needle to be used.After collecting data, we used the Fisher's exact test in order to compare the results P <0.05. There was no difference (P = 1.0) regarding introduction, exposition and removal of the needles. The values of sensitivity (92% for needles A and B), specificity (100% × 80%), positive predictive value (100% × 95.8%), negative predictive value (71.4% × 66.6%) and accuracy (93.3% for needle A and 90% for needle B) were not statistically different. The duration of the procedure was the only analyzed parameter, in which we observed a difference between the needles. For needle A, the average time was 2 min 26 s (1 min 30 s-4 min 0 s) and for needle B the average time was 11 min 7 s (6 min 0 s-17 min 0 s).Even though, the 22 gauge EchoTip(®) ProCore™ HD and the 22 gauge EchoTip(®) Ultra HD endoscopic ultrasound needles had similar overall results, the ProCore™ needle allowed a much quicker procedure.