MULTICENTER RANDOMIZED TRIAL COMPARING THE HISTOLOGICAL MATERIAL QUANTITY OBTAINED BY EUS-FNB OF PANCREATIC MASSES WITH THE 20-GAUGE PROCORE AND THE 22-GAUGE ACQUIRE NEEDLES

Aims Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) has been proposed to obtain high-quality tissue samples for pancreatic tumors. We performed a multicenter randomized crossover trial comparing EUS-FNB with a 20-gauge Procore needle versus a 22-gauge Acquire needle. Our primary and secondary aims were the quantity of targeted tissue (pancreas) obtained and tumor characterization.

Methods 60 patients admitted for EUS-FNB in three endoscopy units were included. One pass was performed consecutively with each needle, in a randomized order. Histological material was studied in a blinded manner with respect to the needle. The primary endpoint was the mean cumulative length of tissue core biopsies per needle pass, measured manually. A computer-assisted surface area measurement was also performed (Aperio software). The secondary endpoint was final diagnosis.

Results Final diagnosis was adenocarcinoma (46 cases/77%), neuroendocrine neoplasm (11 cases/18%), auto-immune pancreatitis (2 cases), and mass-forming chronic pancreatitis (1 case). Histological diagnosis was achieved in 40 out of 60 patients (67%) with the 20-gauge Procore needle and in 52 out of 60 patients (87%) with the 22-gauge Acquire needle (P< 0.02). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22-gauge Acquire needle with 11.36±9.3mm versus 5.42±6.3mm for the 20-gauge Procore needle (P< 0.0001), as was the mean surface area (3.48±3.1mm² versus 1.77±2.0mm², P< 0.001).

Conclusions Our results suggest significant differences, with tumor characterization and mean cumulative length/surface area of tissue core biopsies significantly higher with the 22-gauge Acquire needle than with the 20-gauge Procore.

ClinicalTrials.gov ID: NCT03567863