Abstract：
UNASSIGNED: This pilot study aimed to evaluate safety and tissue sampling from subepithelial lesions (SEL) in the upper gastrointestinal tract with a novel electric motor driven endoscopic ultrasonography (EUS)-guided 17-gauge (G) size core needle biopsy (CNB) instrument.
UNASSIGNED: An investigator-led prospective open label, performance and safety control study, including seven patients (female n = 4, median 71 y, range 28-75) with a determined SEL (median size 30 mm, range 17-150 mm) in the upper digestive tract (stomach n = 6, duodenum n = 1) were eligible and later followed up 14 days after index procedure. All investigations were completed according to protocol with three FNB 22-G passes with four fanning strokes and two EndoDrill® 17-G passes with three fanning strokes.
UNASSIGNED: Quality of samples as \'visible pieces\' (>5 mm): FNB (n = 5/7) (fragmented/blood imbibed n = 1, poor tissue quantity n = 1) compared with 17-G CNB (n = 7/7). Histological result which led to final diagnosis (leiomyoma n = 2, adenocarcinoma n = 1, schwannoma n = 1, neuroendocrine tumour n = 1, desmoid tumour n = 1 and gastrointestinal stromal tumour (GIST) n = 1) could be obtained with the 17-G CNB instrument in all seven patients. FNB technique reached correct diagnosis in six patients. No serious adverse event were recorded.
UNASSIGNED: By using an electric driven 17-G biopsy device, a true cylinder of core tissue can be obtained in one single puncture from the area of interest reducing the need for a second sampling. The absolute benefit of EUS-guided CNB is that the sample can be handled and histologically prepared in the same manner as standard percutaneous core needle sample, e.g., breast and prostate cancer.
UNASSIGNED: An investigator-led prospective open label, performance and safety control study, including seven patients (female n = 4, median 71 y, range 28-75) with a determined SEL (median size 30 mm, range 17-150 mm) in the upper digestive tract (stomach n = 6, duodenum n = 1) were eligible and later followed up 14 days after index procedure. All investigations were completed according to protocol with three FNB 22-G passes with four fanning strokes and two EndoDrill® 17-G passes with three fanning strokes.
UNASSIGNED: Quality of samples as \'visible pieces\' (>5 mm): FNB (n = 5/7) (fragmented/blood imbibed n = 1, poor tissue quantity n = 1) compared with 17-G CNB (n = 7/7). Histological result which led to final diagnosis (leiomyoma n = 2, adenocarcinoma n = 1, schwannoma n = 1, neuroendocrine tumour n = 1, desmoid tumour n = 1 and gastrointestinal stromal tumour (GIST) n = 1) could be obtained with the 17-G CNB instrument in all seven patients. FNB technique reached correct diagnosis in six patients. No serious adverse event were recorded.
UNASSIGNED: By using an electric driven 17-G biopsy device, a true cylinder of core tissue can be obtained in one single puncture from the area of interest reducing the need for a second sampling. The absolute benefit of EUS-guided CNB is that the sample can be handled and histologically prepared in the same manner as standard percutaneous core needle sample, e.g., breast and prostate cancer.
摘要：
■这项初步研究旨在使用新型电动驱动的内窥镜超声检查（EUS）引导的17号（G）尺寸芯针活检（CNB）仪器评估上消化道上皮下病变（SEL）的安全性和组织采样。
■研究者主导的前瞻性开放标签，性能和安全控制研究，包括7名患者(女性n=4，中位数71岁，范围28-75)，具有确定的SEL(中值尺寸30毫米，上消化道（胃n=6，十二指肠n=1）的范围为17-150mm），随后在索引程序后14天进行了随访。所有研究均根据协议完成，使用四次FNB22-G通过和两次EndoDrill®17-G通过和三次扇动通过。
■与17-GCNB（n=7/7）相比，样品的质量为“可见碎片”（>5mm）：FNB（n=5/7）（碎片/血液吸收n=1，组织数量不良n=1）。可以获得最终诊断的组织学结果（平滑肌瘤n=2，腺癌n=1，神经鞘瘤n=1，神经内分泌肿瘤n=1，韧带样肿瘤n=1和胃肠道间质瘤（GIST）n=1）。所有7例患者的17-GCNB仪器。FNB技术在6例患者中达到了正确的诊断。无严重不良事件记录。
■通过使用电动驱动的17-G活检装置，可以在一次穿刺中从感兴趣的区域获得真正的核心组织圆柱体,从而减少对第二次采样的需要。EUS引导的CNB的绝对好处是可以以与标准经皮芯针样品相同的方式处理和组织学制备样品，例如，乳腺癌和前列腺癌.
■研究者主导的前瞻性开放标签，性能和安全控制研究，包括7名患者(女性n=4，中位数71岁，范围28-75)，具有确定的SEL(中值尺寸30毫米，上消化道（胃n=6，十二指肠n=1）的范围为17-150mm），随后在索引程序后14天进行了随访。所有研究均根据协议完成，使用四次FNB22-G通过和两次EndoDrill®17-G通过和三次扇动通过。
■与17-GCNB（n=7/7）相比，样品的质量为“可见碎片”（>5mm）：FNB（n=5/7）（碎片/血液吸收n=1，组织数量不良n=1）。可以获得最终诊断的组织学结果（平滑肌瘤n=2，腺癌n=1，神经鞘瘤n=1，神经内分泌肿瘤n=1，韧带样肿瘤n=1和胃肠道间质瘤（GIST）n=1）。所有7例患者的17-GCNB仪器。FNB技术在6例患者中达到了正确的诊断。无严重不良事件记录。
■通过使用电动驱动的17-G活检装置，可以在一次穿刺中从感兴趣的区域获得真正的核心组织圆柱体,从而减少对第二次采样的需要。EUS引导的CNB的绝对好处是可以以与标准经皮芯针样品相同的方式处理和组织学制备样品，例如，乳腺癌和前列腺癌.
