Background and Aims

EUS-guided choledochoduodenostomy (EUS-CD) using a lumen-apposing metal stent (LAMS) has recently been reported as an alternative treatment approach for patients with malignant obstructive jaundice and failed ERCP. We analyzed the safety and technical and clinical efficacy of EUS-CD using LAMSs in patients with malignant obstructive jaundice.

Methods

This was a retrospective study of consecutive patients with inoperable malignant distal bile duct obstruction who underwent EUS-CD using an electrocautery-enhanced (EC)-LAMS over a 3-year period (2015-2018). The main outcome measures were technical and clinical success (defined as a decline in serum bilirubin level by 50% at 2-week follow-up). Secondary outcomes were occurrence of adverse events, procedure time, and stent patency.

Results

Forty-six patients (47.8% women; median age, 73.1 ± 12.6 years) underwent direct EUS-CD using the biliary EC-LAMS. The procedure was technically successful in 43 patients (93.5%). The rate of clinical success was 97.7%. Adverse events occurred in 5 (11.6%) patients and included the following: 1 fatal bleeding 17 days after stent placement, 3 episodes of stent occlusion (food impaction), and 1 spontaneous migration (all 4 requiring reintervention). The mean follow-up was 114.37 days (95% confidence interval, 73.2-155.4).

Conclusions

EUS-CD using the EC-LAMS is effective. The rate of adverse events including one fatal event is not negligible and should be carefully considered before using the stent in this clinical setting. Prospective studies are required to validate our preliminary findings to fully assess the long-term efficacy and safety of the stent.

中文翻译：

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单阶段EUS引导的胆管十二指肠吻合术，使用带腔的金属支架治疗远端胆道恶性梗阻

背景和目标

最近报道了使用腔内金属支架（LAMS）进行EUS引导的胆总管十二指肠吻合术（EUS-CD）作为恶性阻塞性黄疸和ERCP失败的患者的替代治疗方法。我们分析了使用LAMSs对恶性阻塞性黄疸患者进行EUS-CD的安全性，技术和临床疗效。

方法

这是一项回顾性研究，对连续三年无法手术的恶性远端胆管梗阻患者行电灼增强（EC）-LAMS进行了为期3年（2015-2018年）的EUS-CD治疗。主要结局指标是技术和临床成功率（定义为在2周的随访中血清胆红素水平下降50％）。次要结果是不良事件的发生，手术时间和支架通畅。

结果

46例患者（女性47.8％；中位年龄73.1±12.6岁）接受了通过胆管EC-LAMS直接进行EUS-CD治疗。该手术在技术上成功地治疗了43例患者（93.5％）。临床成功率为97.7％。不良事件发生在5位（11.6％）患者中，包括：1在放置支架后17天发生致命性出血，3次发生支架阻塞（食物撞击）和1次自发迁移（所有4例都需要再次干预）。平均随访时间为114.37天（95％置信区间为73.2-155.4）。

结论

使用EC-LAMS的EUS-CD是有效的。包括一个致命事件在内的不良事件发生率不可忽略，在此临床环境中使用该支架之前应仔细考虑。需要进行前瞻性研究来验证我们的初步发现，以充分评估支架的长期疗效和安全性。