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A pilot proof-of-concept study of a modified device for one-step endoscopic ultrasound-guided biliary drainage in a new experimental biliary dilatation animal model

机译:在新型实验性胆管扩张动物模型中对一步式内窥镜超声引导胆汁引流的改良装置的概念性试验研究

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摘要

AIM: To evaluate the technical feasibility of a modified tapered metal tip and low profile introducer for one-step endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) in a new experimental biliary dilatation porcine model.METHODS: A novel dedicated device for one-step EUS-guided biliary drainage system (DEUS) introducer has size 3F tapered catheter with size 4F metal tip for simple puncture of the intestinal wall and liver parenchyma without graded dilation. A self-expandable metal stent, consisting of both uncovered and nitinol-covered portions, was preloaded into DEUS introducer. After establishment of a biliary dilatation model using endoscopic hemoclips or band ligation with argon plasma coagulation in 9 mini-pigs, EUS-BD using a DEUS was performed following 19-G needle puncture without the use of fistula dilation devices.RESULTS: One-step EUS-BD was technically successful in seven pigs [7/9 (77.8%) as intention to treat] without the aid of devices for fistula dilation from the high body of stomach or far distal esophagus to the intrahepatic (n = 2) or common hepatic (n = 5) duct. Primary technical failure occurred in two cases that did not show adequate biliary dilatation. In seven pigs with a successful bile duct dilatation, the technical success rate was 100% (7/7 as per protocol). Median procedure time from confirmation of the dilated bile duct to successful placement of a metallic stent was 10 min (IQR; 8.9-18.1). There were no immediate procedure-related complications.CONCLUSION: Modified tapered metal tip and low profile introducer may be technically feasible for one-step EUS-BD in experimental porcine model.
机译:目的:在一种新的实验性胆管扩张猪模型中,评估改良的锥形金属尖端和低轮廓导引器用于单步内窥镜超声(EUS)引导的胆汁引流(EUS-BD)的技术可行性。用于一步式EUS引导胆汁引流系统(DEUS)的导引器具有3F尺寸的锥形导管和4F的金属尖端,可简单穿刺肠壁和肝实质,而无需分级扩张。将由未覆盖部分和镍钛合金覆盖部分组成的自膨胀金属支架预装到DEUS导引器中。使用内窥镜止血钳或带结扎的氩气血浆凝结法在9只小型猪中建立胆管扩张模型后,在进行19-G针穿刺后使用DEUS进行EUS-BD,而无需使用瘘管扩张装置。 EUS-BD技术成功地对七只猪进行了治疗[7/9(77.8%)(打算治疗)],而无需借助从胃高处或远端食管到肝内(n = 2)或常见的瘘管扩张装置肝(n = 5)导管。原发性技术衰竭发生在两例未表现出足够的胆道扩张的病例中。在成功进行胆管扩张的七只猪中,技术成功率为100%(根据协议为7/7)。从确认胆管扩张到成功放置金属支架的中位时间为10分钟(IQR; 8.9-18.1)。结论:改良的锥形金属尖端和低轮廓导引器在实验猪模型中一步一步EUS-BD技术上可行。

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