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

ABSTRACT

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.