Shigetaka Yoshinaga1, Takao Itoi2, Kenji Yamao3, Ichiro Yasuda4,5, Atsushi Irisawa6,7, Hiroshi Imaoka3,8, Takayoshi Tsuchiya2, Shinpei Doi4,9, Akane Yamabe6,7, Yoshitaka Murakami10, Hideki Ishikawa11, Yutaka Saito1. 1. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan. 2. Department of Gastroenterology and Hepatology, Tokyo Medical University, Japan. 3. Department of Gastroenterology, Aichi Cancer Center Hospital, Aichi, Japan. 4. First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan. 5. Third Department of Internal Medicine, University of Toyama, Toyama, Japan. 6. Department of Gastroenterology, Dokkyo Medical University, Tochigi, Japan. 7. Department of Gastroenterology, Aizu Medical Center, Fukushima Medical University, Fukushima, Japan. 8. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan. 9. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan. 10. Department of Medical Statistics, Toho University, Tokyo, Japan. 11. Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Abstract
OBJECTIVES: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for solid pancreatic lesions has high diagnostic yield. However, few prospective multicenter studies have been performed. We performed a prospective cohort study to evaluate the efficacy and safety of EUS-FNA for diagnosis of solid pancreatic lesions. METHODS: This prospective cohort study involved five hospitals in Japan. The primary outcome was sensitivity of EUS-FNA for diagnosing malignant lesions. We also evaluated parameters of diagnostic sufficiency and the safety of EUS-FNA. RESULTS: In total, 246 patients were enrolled. The absolute values of the parameters evaluated showed no significant differences; however, the percentage changes in the white blood cell counts and C-reactive protein levels after examination were significantly higher, and the percentage change in hemoglobin concentrations was significantly lower. The minor and major complication rates at the time of puncture, 24 h, 7 days and 28 days were 4.1%, 2.8%, 1.6%, and 0.0%, respectively. The true complication rate was 1.2%. The diagnostic sensitivity, specificity, accuracy, positive predictive value, and negative predictive value were 97.2%, 88.0%, 96.2%, 100%, and 81.4%, respectively. CONCLUSIONS: EUS-FNA for solid pancreatic lesions has high diagnostic yield and is safe, consistent with previously studies.
OBJECTIVES: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for solid pancreatic lesions has high diagnostic yield. However, few prospective multicenter studies have been performed. We performed a prospective cohort study to evaluate the efficacy and safety of EUS-FNA for diagnosis of solid pancreatic lesions. METHODS: This prospective cohort study involved five hospitals in Japan. The primary outcome was sensitivity of EUS-FNA for diagnosing malignant lesions. We also evaluated parameters of diagnostic sufficiency and the safety of EUS-FNA. RESULTS: In total, 246 patients were enrolled. The absolute values of the parameters evaluated showed no significant differences; however, the percentage changes in the white blood cell counts and C-reactive protein levels after examination were significantly higher, and the percentage change in hemoglobin concentrations was significantly lower. The minor and major complication rates at the time of puncture, 24 h, 7 days and 28 days were 4.1%, 2.8%, 1.6%, and 0.0%, respectively. The true complication rate was 1.2%. The diagnostic sensitivity, specificity, accuracy, positive predictive value, and negative predictive value were 97.2%, 88.0%, 96.2%, 100%, and 81.4%, respectively. CONCLUSIONS: EUS-FNA for solid pancreatic lesions has high diagnostic yield and is safe, consistent with previously studies.