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超声内镜引导下经皮经肝胆道引流术(附视频)中 19 号针与.025 英寸导丝和 22 号针与新型.018 英寸导丝的前瞻性对比研究

Prospective comparison study between 19-gauge needle with .025-inch guidewire and 22-gauge needle with novel .018-inch guidewire during EUS-guided transhepatic biliary drainage (with video).

机构信息

2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan.

出版信息

Gastrointest Endosc. 2022 Aug;96(2):262-268.e1. doi: 10.1016/j.gie.2022.03.013. Epub 2022 Mar 14.

Abstract

BACKGROUND AND AIMS

If the diameter of the intrahepatic bile duct is much less dilated, bile duct puncture with a 19-gauge needle can be challenging during EUS-guided biliary drainage (EUS-BD). These characteristics can decrease the difficulty of bile duct puncture, but use of a 22-gauge needle is less feasible because of poor visibility, maneuverability, and stiffness of the conventional .018-inch guidewire. A novel, improved .018-inch guidewire has recently become available. We conducted a prospective study to evaluate the technical feasibility and safety of EUS-BD in patients with insufficient bile duct dilatation using a 22-gauge needle and the new .018-inch guidewire.

METHODS

A 22-gauge needle was used as the puncture needle for intrahepatic bile ducts of diameters <1.5 mm, and a 19-gauge needle was selected for diameters ≥1.5 mm. As the primary endpoint of the study, the technical success rate of EUS-BD using a 22-gauge needle with the novel .018-inch guidewire was evaluated in patients with insufficient dilation of the intrahepatic bile duct.

RESULTS

Forty-one patients who required EUS-BD were enrolled (22-gauge needle group, n = 18; 19-gauge needle group, n = 23). Technical success was obtained in all patients in the 19-gauge needle group. In the 22-gauge needle group, technical failure occurred in 2 patients because of nonidentification of the intrahepatic bile duct on EUS (technical success rate, 88.9%), and puncture of the bile duct itself was not performed in these patients. Mean procedure time was similar between the groups. Adverse events were observed in 16.7% of patients (3/16) in the 22-gauge needle group and in 34.8% of patients (8/23) in the 19-gauge needle group.

CONCLUSIONS

Outcomes of using a 22-gauge needle with a novel .018-inch guidewire were comparable with a 19-gauge needle with a .025-inch guidewire, even in the case of insufficient intrahepatic bile duct dilatation. These results require verification in a prospective, randomized trial comparing 22-gauge and 19-gauge needles with a larger sample size. (Clinical trial registration number: UMIN000044441.).

摘要

背景和目的

如果肝内胆管直径扩张较小,在超声内镜引导下胆道引流(EUS-BD)时,使用 19 号针进行胆管穿刺可能具有挑战性。这些特征可以降低胆管穿刺的难度,但由于常规.018 英寸导丝的可视性、可操作性和柔韧性较差,使用 22 号针不太可行。一种新型改良的.018 英寸导丝最近已经问世。我们进行了一项前瞻性研究,以评估使用新型.018 英寸导丝的 22 号针在肝内胆管直径<1.5mm 的患者中行 EUS-BD 的技术可行性和安全性。

方法

对于直径<1.5mm 的肝内胆管,使用 22 号针作为穿刺针,对于直径≥1.5mm 的胆管,选择 19 号针。作为研究的主要终点,评估使用新型.018 英寸导丝的 22 号针在肝内胆管扩张不足的患者中行 EUS-BD 的技术成功率。

结果

共纳入 41 例需要 EUS-BD 的患者(22 号针组 n=18;19 号针组 n=23)。19 号针组所有患者均获得技术成功。在 22 号针组,由于超声内镜(EUS)上无法识别肝内胆管,有 2 例患者发生技术失败(技术成功率为 88.9%),这些患者未进行胆管穿刺。两组患者的平均手术时间相似。22 号针组 16.7%(3/16)的患者和 19 号针组 34.8%(8/23)的患者出现不良事件。

结论

即使在肝内胆管扩张不足的情况下,使用新型.018 英寸导丝的 22 号针的结果与使用.025 英寸导丝的 19 号针相当。这些结果需要在一项前瞻性、随机试验中通过更大的样本量比较 22 号针和 19 号针来验证。(临床试验注册号:UMIN000044441。)

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