Background and Objectives During EUS-guided choledochoduodenostomy (EUS-CDS), fistula dilation before stent insertion is associated with adverse events (AEs), such as bile leakage and peritonitis. We hypothesized that EUS-CDS without fistula dilation using a novel self-expandable metal stent (SEMS) with a thin delivery system could overcome this problem, and we conducted this study to evaluate its feasibility and safety. Methods This was an open-label, single-arm, phase II study at a single institution. We planned EUS-CDS without fistula dilation using a fully covered SEMS with a 5.9-Fr delivery system for unresectable malignant distal biliary obstruction. The primary outcome was overall technical success. Secondary outcomes were technical success without fistula dilation, procedure time, functional success, time to recurrent biliary obstruction, and AEs. The planned sample size was 25 patients. Results In total, 24 patients were included in this study. In 21 patients, EUS-CDS was performed as primary drainage. The overall technical success rate was 100% (24 of 24 patients). The technical success rate without fistula dilation was 96% (23 of 24). The median procedure time was 16 min (range, 10-66 min). The functional success rate was 96% (23 of 24). The median time to recurrent biliary obstruction was 148 days (95% confidence interval, 29-266 days). There were no procedure-related AEs. Furthermore, computed tomography immediately after the procedure showed no leakage of contrast medium into the abdominal cavity in any patient. Conclusions EUS-guided choledochoduodenostomy without fistula dilation using a fully covered SEMS with a 5.9-Fr delivery system is feasible with a high probability and can be achieved quickly while effectively preventing bile leakage and peritonitis.

中文翻译：

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EUS引导下不进行瘘管扩张的胆总管十二指肠吻合术治疗恶性远端胆道梗阻的前瞻性临床试验。

背景和目标 在 EUS 引导下的胆总管十二指肠吻合术 (EUS-CDS) 过程中，支架插入前的瘘管扩张与不良事件 (AE) 有关，例如胆漏和腹膜炎。我们假设使用具有薄输送系统的新型自扩张金属支架（SEMS）而无需进行瘘管扩张的 EUS-CDS 可以克服这个问题，我们进行了这项研究来评估其可行性和安全性。方法 这是一项在单一机构进行的开放标签、单臂、II 期研究。我们计划使用带有 5.9-Fr 输送系统的全覆盖 SEMS 进行 EUS-CDS，无需进行瘘管扩张，以治疗不可切除的恶性远端胆道梗阻。主要成果是总体技术成功。次要结局是无瘘管扩张的技术成功、手术时间、功能成功、复发性胆道梗阻时间和 AE。计划样本量为 25 名患者。结果 本研究总共纳入 24 名患者。在 21 名患者中，进行了 EUS-CDS 作为主要引流术。总体技术成功率为 100%（24 名患者中的 24 名）。不进行瘘管扩张的技术成功率为 96%（24 例中的 23 例）。中位手术时间为 16 分钟（范围：10-66 分钟）。功能成功率为 96%（24 例中的 23 例）。复发性胆道梗阻的中位时间为 148 天（95% 置信区间，29-266 天）。没有出现与手术相关的 AE。此外，手术后立即进行的计算机断层扫描显示，任何患者都没有造影剂渗漏到腹腔中。结论 EUS引导下无瘘管扩张的胆总管十二指肠吻合术，采用全覆盖SEMS和5.9-Fr输送系统，可行性高，可快速实现，同时有效预防胆漏和腹膜炎。