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-g...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.展开更多
BACKGROUND Reverse bevel(RB)needle is widely used for endoscopic ultrasound fine needle biopsy(EUS-FNB).A 3-plane symmetrical needle with Franseen geometry(FG)has recently become available.AIM To compare the clinical ...BACKGROUND Reverse bevel(RB)needle is widely used for endoscopic ultrasound fine needle biopsy(EUS-FNB).A 3-plane symmetrical needle with Franseen geometry(FG)has recently become available.AIM To compare the clinical efficacy of FG to that of RB needle.METHODS A retrospective cohort study of all adult patients who underwent EUS-FNB for solid and mixed lesions either with 22G RB needle or 22G FG needle between January 2016 and February 2019 was undertaken.All cytology slides were reviewed by an independent gastrointestinal cytopathologist blinded to the needle used and the initial cytology report.The primary and secondary outcomes were to assess the sample adequacy using Euro-cytology criteria and the number of cell clusters,respectively.RESULTS Two hundred and twenty six procedures were included in the study.RB needle was used in 128 procedures and FG needle in 98 procedures.The baseline characteristics of both groups were comparable.On multivariable analysis,FG needle(P=0.02)and location of the lesion(P<0.01)were independently associated with adequate tissue.Further,the use of FG needle(P=0.04)and the size of the lesion(P=0.02)were independently associated with acquisition of increased number of cell clusters.CONCLUSION FG needle is superior to RB needle in acquiring adequate tissue and attaining higher number of cell clusters for solid and mixed lesions.展开更多
BACKGROUND The introduction of fine needle biopsies(FNB)to clinical practice presents a changing trend towards histology in the endoscopic ultrasound-guided tissue acquisition(EUS-TA).AIM To evaluate the clinical perf...BACKGROUND The introduction of fine needle biopsies(FNB)to clinical practice presents a changing trend towards histology in the endoscopic ultrasound-guided tissue acquisition(EUS-TA).AIM To evaluate the clinical performance of a new FNB needle,the 22-gauge(22G)Franseen needle,when sampling pancreatic solid lesions.METHODS Consecutive patients with an indication for EUS-TA for the assessment of pancreatic solid lesions were included in this prospective,single-center,singlearm trial.Each patient underwent a puncture of the lesion two times using the 22G Franseen needle and the obtained samples were directly placed into formalin for histological analysis.The primary study endpoint was the rate of high-quality obtained specimen.Secondary endpoints included the length and diameter of the core specimen,the diagnostic accuracy and the complication rate.RESULTS From June 2017 to December 2018,forty patients with pancreatic solid lesions(22 females;mean age 67.2 years)were enrolled.Tissue acquisition was achieved in all cases.High-quality histology,rated with Payne score 3,was obtained in 37/40 cases(92.5%)after two needle passes.The mean size of the acquired histological core tissue was 1.54 mm×0.39 mm.The diagnostic accuracy for the correct diagnosis was 85%(34/40).Only one adverse event was occurred,consisting of a self-limiting bleeding in the puncture site.CONCLUSION The 22G Franseen needle achieved according to our standardized protocol a high rate of histological core procurement,and a high diagnostic accuracy,with one minor adverse event reported.展开更多
文摘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.
基金We thank the colleagues of Department of Pathology in Queen’s Medical Centre, Nottingham for their help in specimen slides retrieval.
文摘BACKGROUND Reverse bevel(RB)needle is widely used for endoscopic ultrasound fine needle biopsy(EUS-FNB).A 3-plane symmetrical needle with Franseen geometry(FG)has recently become available.AIM To compare the clinical efficacy of FG to that of RB needle.METHODS A retrospective cohort study of all adult patients who underwent EUS-FNB for solid and mixed lesions either with 22G RB needle or 22G FG needle between January 2016 and February 2019 was undertaken.All cytology slides were reviewed by an independent gastrointestinal cytopathologist blinded to the needle used and the initial cytology report.The primary and secondary outcomes were to assess the sample adequacy using Euro-cytology criteria and the number of cell clusters,respectively.RESULTS Two hundred and twenty six procedures were included in the study.RB needle was used in 128 procedures and FG needle in 98 procedures.The baseline characteristics of both groups were comparable.On multivariable analysis,FG needle(P=0.02)and location of the lesion(P<0.01)were independently associated with adequate tissue.Further,the use of FG needle(P=0.04)and the size of the lesion(P=0.02)were independently associated with acquisition of increased number of cell clusters.CONCLUSION FG needle is superior to RB needle in acquiring adequate tissue and attaining higher number of cell clusters for solid and mixed lesions.
文摘BACKGROUND The introduction of fine needle biopsies(FNB)to clinical practice presents a changing trend towards histology in the endoscopic ultrasound-guided tissue acquisition(EUS-TA).AIM To evaluate the clinical performance of a new FNB needle,the 22-gauge(22G)Franseen needle,when sampling pancreatic solid lesions.METHODS Consecutive patients with an indication for EUS-TA for the assessment of pancreatic solid lesions were included in this prospective,single-center,singlearm trial.Each patient underwent a puncture of the lesion two times using the 22G Franseen needle and the obtained samples were directly placed into formalin for histological analysis.The primary study endpoint was the rate of high-quality obtained specimen.Secondary endpoints included the length and diameter of the core specimen,the diagnostic accuracy and the complication rate.RESULTS From June 2017 to December 2018,forty patients with pancreatic solid lesions(22 females;mean age 67.2 years)were enrolled.Tissue acquisition was achieved in all cases.High-quality histology,rated with Payne score 3,was obtained in 37/40 cases(92.5%)after two needle passes.The mean size of the acquired histological core tissue was 1.54 mm×0.39 mm.The diagnostic accuracy for the correct diagnosis was 85%(34/40).Only one adverse event was occurred,consisting of a self-limiting bleeding in the puncture site.CONCLUSION The 22G Franseen needle achieved according to our standardized protocol a high rate of histological core procurement,and a high diagnostic accuracy,with one minor adverse event reported.
