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超声内镜引导下胆道引流用可控导丝输送装置的初步临床经验。

Initial clinical experience of a steerable access device for EUS-guided biliary drainage.

机构信息

Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Division of Gastroenterology, Northwell Health, North Shore University Hospital, Manhasset, New York, USA.

出版信息

Gastrointest Endosc. 2020 Jan;91(1):178-184. doi: 10.1016/j.gie.2019.07.035. Epub 2019 Aug 10.

DOI:10.1016/j.gie.2019.07.035
PMID:31408653
Abstract

BACKGROUND AND AIMS

EUS-guided biliary drainage (EUS-BD) has been used as a rescue procedure after failed endoscopic retrograde cholangiography (ERC), and there is growing interest in EUS-BD as a primary therapy for distal malignant biliary obstruction. After EUS-guided needle puncture of an obstructed bile duct, directional control of wire advancement remains an area of need, potentially addressed by a new steerable EUS access system. The aim of this study was to evaluate the safety and efficacy of this novel steerable access system in patients undergoing EUS-BD after failed ERC.

METHODS

We performed a retrospective study of prospectively acquired data at 3 tertiary academic hospitals. Consecutive patients who had failed ERC followed by EUS-BD using the access device were included. Primary outcomes were safety and technical feasibility (successful completion of EUS-BD). Secondary outcomes were clinical success (75% improvement in liver function tests at 30 days) and device performance.

RESULTS

Twenty-two consecutive patients underwent EUS-BD between October 10, 2018 and March 3, 2019. Needle puncture and selective wire advancement in the intended direction were both successful in 100% of cases (22/22). Technical success was 95% (21/22). Fifty-nine percent (13) underwent rendezvous, 32% (7) underwent choledochoduodenostomy, and 4.5% (1) underwent hepaticogastrostomy. One patient (4.5%) underwent percutaneous transhepatic cholangiography. There were no cases of wire shearing. The adverse event rate was 4.5% (mild pancreatitis in 1 patient). There was no bile leak, bleeding, or death at 30 days' follow-up.

CONCLUSIONS

This first clinical experience with a steerable access system for EUS-BD suggests it is safe and effective, particularly with regard to controlling direction of wire advancement.

摘要

背景和目的

超声内镜引导下胆道引流术(EUS-BD)已被用作内镜逆行胰胆管造影术(ERC)失败后的抢救措施,并且越来越多的人对 EUS-BD 作为治疗远端恶性胆道梗阻的主要方法感兴趣。在超声内镜引导下对阻塞的胆管进行针穿刺后,导丝推进的方向控制仍然是一个需要解决的问题,这一问题可能可以通过一种新的可转向超声内镜进入系统来解决。本研究的目的是评估该新型可转向进入系统在 ERC 失败后行 EUS-BD 患者中的安全性和有效性。

方法

我们在 3 家三级学术医院进行了前瞻性数据的回顾性研究。纳入了连续因 ERC 失败后接受该进入装置行 EUS-BD 的患者。主要结局是安全性和技术可行性(EUS-BD 成功完成)。次要结局是临床成功率(30 天时肝功能检查改善 75%)和器械性能。

结果

2018 年 10 月 10 日至 2019 年 3 月 3 日期间,连续 22 例患者接受了 EUS-BD。100%(22/22)的患者均成功进行了针穿刺和在预期方向上选择性导丝推进。技术成功率为 95%(21/22)。59%(13/22)的患者进行了会师法,32%(7/22)的患者进行了胆肠吻合术,4.5%(1/22)的患者进行了肝胃吻合术。1 例(4.5%)患者进行了经皮经肝胆管造影术。没有发生导丝剪断的情况。不良事件发生率为 4.5%(1 例轻度胰腺炎)。在 30 天随访时,没有发生胆漏、出血或死亡。

结论

这是首例关于超声内镜引导下胆道引流术的可转向进入系统的临床经验,该系统安全有效,尤其在控制导丝推进方向方面。

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