Fine-needle aspiration of pancreatic cystic lesions: a randomized study with long-term follow-up comparing standard and flexible needles

作者：Mohammad Al‐Haddad, Michael B. Wallace, William R. Brugge, Sundeep Lakhtakia, Zhao-Shen Li, Amrita Sethi, Douglas K. Pleskow, Cuong C. Nguyen, Rahul Pannala, John M. DeWitt, Massimo Raimondo, Timothy A. Woodward, Mohan Ramchandani, Zhendong Jin, Can Xu, Douglas O. Faigel · 发表于：Endoscopy · 年份：2020 · DOI：10.1055/a-1311-9927 · 被引用次数：8 · 研究领域：Pancreatic and Hepatic Oncology Research、Salivary Gland Tumors Diagnosis and Treatment、Pleural and Pulmonary Diseases

Abstract Background Pancreatic cystic lesions (PCLs) are increasingly found on cross-sectional imaging, with the majority having a low risk for malignancy. The added value of fine-needle aspiration (FNA) in risk stratification remains unclear. We evaluated the impact of three FNA needles on diagnostic accuracy, clinical management, and the ability to accrue fluid for tumor markers. Methods A multicenter prospective trial randomized 250 patients with PCLs ≥ 13 mm 2:1:1 to 19G Flex, 19G, and 22G needles with crossover for repeated FNA procedures. Diagnostic accuracy was established at 2-year follow-up, with the final diagnosis from surgical histopathology or consensus diagnosis by experts based sequentially on clinical presentation, imaging, and aspirate analysis in blinded review. Results Enrolled patients (36 % symptomatic) had PCLs in the head (44 %), body (28 %), and tail (26 %). Percentage of cyst volume aspirated was 78 % (72 % – 84 %) for 19G Flex, 74 % (64 % – 84 %) for 22G, and 73 % (63 % – 83 %) for 19G (P = 0.84). Successful FNA was significantly higher for 19G Flex (89 % [82 % – 94 %]) and 22G (82 % [70 % – 90 %]) compared with 19G (75 % [63 % – 85 %]) (P = 0.02). Repeated FNA was required more frequently in head/uncinate lesions than in body and tail (P < 0.01). Diagnostic accuracy of the cyst aspirate was 84 % (73 % – 91 %) against histopathology at 2-year follow-up (n = 79), and 77 % (70 % – 83 %) against consensus diagnosis among nonsurgical cases (n = 171). ...