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

Introduction: 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.

Aims: The present study intends to compare the results obtained by these two needles when performing EUS-FNA of pancreatic solid lesions.

Patients and methods: 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.

Results: 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).

Conclusion: 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.