Prospective randomized study comparing Franseen 22-gauge vs standard 22-gauge needle for endoscopic ultrasound guided sampling of pancreatic solid lesions  

作　　者：Gabriela F Paduani Leika M Felipe Gustavo A De Paulo Luciano Lenz Bruno C Martins Sergio E Matuguma Adriana V Safatle-Ribeiro Evandro S De Mello Fauze Maluf-Filho 

机构地区：[1]Department of Gastroenterology,Instituto do Cancer do Estado de Sao Paulo,Sao Paulo 01246-000,Brazil [2]Department of Pathology,Instituto do Cancer,Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo,Sao Paulo 01246-000,Brazil

出　　处：《World Journal of Gastrointestinal Endoscopy》2025年第4期42-51,共10页世界胃肠内镜杂志(英文)

摘　　要：BACKGROUND This is a randomized study to compare the diagnostic accuracy of endoscopic ultrasound(EUS)-guided sampling of pancreatic solid lesions obtained with the 22-gauge Franseen(EUS-fine needle biopsy)vs the 22-gauge standard needle(EUS-fine needle aspiration)without rapid onsite evaluation(ROSE),since,in most endoscopy units around the world ROSE is not routinely available.AIM To investigate the accuracy of EUS-guided sampling of pancreatic solid lesions obtained between two different needles without ROSE.METHODS Patients with a solid pancreatic were included.Patients were biopsied in a randomized order.The primary endpoint was the diagnostic sensitivity for pancreatic malignancy(PM).Secondary outcomes were adequacy of the sample,the mean tissue area,the mean tumor area,and the adverse event rate.RESULTS The final diagnosis was pancreatic adenocarcinoma in 38(76%),neuroendocrine tumor in 4(8%),chronic pancreatitis in 3(6%)patients.The sensitivity for PM with Franseen needle was 0.91[95%confidence interval(CI):0.80-0.98],vs 0.8(95%CI:0.67-0.91)(P=0.025)with standard needle.The specificity for PM did not differentiate.The accuracy of the standard needle for PM was 0.80(95%CI:0.66-0.90),and the Franseen group was 0.90(95%CI:0.78-0.97)(P=0.074).The technical success rates for the standard and Franseen needle groups were 94%(95%CI:0.83-0.99)and 100%(95%CI:0.92-1.00),respectively.The mean total tissue area in mm2(SD)was greater in the Franseen group,2.07(0.22)vs 1.16(0.17)(P<0.01).The mean tumor area in mm2(SD)was not different in Franseen group vs standard group,0.42(0.09)vs 0.47(0.09)(P=0.80).There were no adverse events.CONCLUSION The sensitivity for PM and mean total tissue area,was greater in the as compared with standard needle.The mean tumor area did not differ between the groups.

关 键 词：Franseen needle Standard needle Endoscopic ultrasound Pancreatic solid lesions Rapid onsite evaluation 

分 类 号：R735.7[医药卫生—肿瘤]