A prospective, randomized, multicenter clinical trial comparing 25-gauge and 20-gauge biopsy needles for endoscopic ultrasound-guided sampling of solid pancreatic lesions

Background Various core biopsy needles have previously been developed for endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). However, the properties of needle gauge in the diagnostic outcomes of solid pancreatic lesions remain unknown. This trial compared the procurement rates of histologic cores from solid pancreatic lesions with EUS-FNB using 20- and 25-gauge (G) FNB needles. Methods In a prospective randomized multicenter clinical trial, patients with solid pancreatic lesions underwent EUS-FNB with either a 20-gauge or a 25-gauge FNB needle. The rates of histologic core procurement, overall diagnostic accuracy, and adverse events were compared between the two groups (20-gauge or 25-gauge FNB needle). Results In total, 88 patients (48 men, 40 women, mean age 65.7 years) were enrolled. No significant differences were found in the demographic characteristics between the two groups (20-gauge or 25-gauge FNB needle). The procurement rate of histologic cores in the 20-guage FNB needle group (41/45, 91.1%) was significantly higher than that in the 25-guage FNB needle group (32/43, 74.4%, P = 0.037). However, no significant differences were found in the overall diagnostic accuracy between 20-guage FNB needle (40/45, 88.9%) and 25-guage FNB needle (34/43, 79.1%, P = 0.208). No procedure-related adverse events were observed in either group. Conclusions Although both FNB needles provided high overall diagnostic accuracy, the reliability of the 20-guage FNB needle is better than the 25-guage FNB needle when retrieving samples for histological analysis.