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Background/Aims: Endoscopic ultrasound-guided fineneedle aspiration (EUS-FNA) is useful for the pathologicaldiagnosis of pancreatic masses, but patients are susceptibleto severe bleeding and perforation. Because the incidenceand severity of these complications have not been fullyevaluated. Methods: We aimed to evaluate severe bleedingand perforation after EUS-FNA for pancreatic masses usinglarge-scale data derived from a Japanese nationwide administrativedatabase. Results: In total, 3,090 consecutive patientsfrom 212 low- to high-volume hospitals were analyzed. Severe bleeding requiring transfusion or endoscopic treatmentoccurred in seven patients (0.23%), and no perforationwas observed. No patient mortality was recorded within 30days of EUS-FNA. The rate of severe bleeding in low-volumehospitals was significantly higher than that in medium- andhigh-volume hospitals (0.48% vs 0.10%, p=0.045). Conclusions:Severe bleeding and perforation following EUS-FNA forpancreatic masses are rare, and the procedure is safe.

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