Prospective assessment of diagnostic utility and complications of endoscopic ultrasound-guided fine needle aspiration. Results from a newly developed academic endoscopic ultrasound program.

BACKGROUND: It is currently unknown whether a newly developed endoscopic ultrasound (EUS) program can produce results similar to those of experienced EUS centers. We therefore prospectively evaluated the diagnostic accuracy and major complications of EUS-guided fine needle aspiration (EUS-FNA) in a newly developed EUS program.

METHODS: All procedures were performed by a single endosonographer in the presence of a cytopathologist. Reference standard for classification of final disease included: surgical resection, death from disease progression and repeat radiologic and/or clinical follow-up. Major complications were defined as oversedation, and those that resulted in a physician or emergency department visits, hospitalization, or death.

RESULTS: 540 patients (median age 63 years, 77% white) underwent EUS-FNAs of 656 lesions: lymph nodes (LNs, n = 248), solid pancreatic masses (SPMs, n = 229), cystic pancreatic masses (CPM, n = 57), mural lesions (n = 41), bile duct/gallbladder (n = 28), liver (n = 17), mediastinum/lung (n = 17), adrenal (n = 15), spleen (n = 3) and kidney (n = 1). SPMs and bile duct/gallbladder lesions were more likely to have suspicious/atypical cytology when compared to other lesions (8.7 vs. 4.6%; p = 0.04) and required more passes to achieve a tissue diagnosis (p < 0.001). The overall sensitivity, specificity, PPV, NPV and accuracy of EUS-FNA was 91.7, 97.1, 98.1, 87.7 and 93.8%, respectively. Six patients (1.1%) (95% CI 0.4-2.4) experienced a major complication. One patient died shortly after the procedure due to preexisting pulmonary embolus (0.18%).

CONCLUSION: EUS-FNA is highly accurate and safe in sampling a variety of peri-intestinal organs and lymph nodes. With adequate third-tier training, a newly developed program can produce results similar to those from expert EUS centers.