Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Department of Gastroenterology and Hepatology, Osaka, Japan.
Dig Endosc. 2019 May;31(3):291-298. doi: 10.1111/den.13300. Epub 2018 Dec 18.
When endoscopic retrograde cholangiopancreatography (ERCP) fails in patients with malignant distal biliary obstruction, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is an alternative. It has high technical and clinical success rates, but also has high adverse event rates. This prospective cohort study was aimed to evaluate the clinical efficacy and safety of EUS-CDS with our newly developed partially covered self-expandable metal stent with a thin delivery system.
Patients consisted of all consecutive patients in three tertiary referral centers with unresectable malignant distal obstruction in whom ERCP failed and in whom EUS-CDS with the thin delivery system was selected as the second-line approach. Rates of clinical success, technical success, technical success in cases not requiring fistulous tract dilation, adverse events, and stent dysfunction were determined.
In the 20 patients, technical and clinical success rates were 95.0% (19/20) and 100% (19/19), respectively. In 31.6% (6/19), the delivery system was successfully inserted into the bile duct without requiring a fistulous-tract dilatation device. These patients had significantly shorter procedure times than patients requiring fistulous-tract dilatation (12.7 ± 3.1 vs 23.2 ± 2.1 min; P < 0.01). One patient (5.0%) who required fistulous dilation had an adverse event, which was managed conservatively. There were no procedure-related deaths. During follow up, four patients (21.1%) developed stent dysfunction. Reintervention was successful in all cases.
The EUS-CDS approach had 95% technical and 100% clinical success rates, with adverse events reported in 5% of cases. EUS-CDS may become safer if efforts are made to avoid the dilation step (UMIN 000023938).
当内镜逆行胰胆管造影术（ERCP）在恶性远端胆道梗阻患者中失败时，内镜超声引导下胆胰管内引流术（EUS-CDS）是一种替代方法。它具有较高的技术和临床成功率，但也有较高的不良事件发生率。本前瞻性队列研究旨在评估我们新开发的带有薄输送系统的部分覆膜自膨式金属支架在 EUS-CDS 中的临床疗效和安全性。
该研究纳入了三个三级转诊中心的所有连续患者，这些患者患有不可切除的恶性远端梗阻，且 ERCP 失败，并选择带有薄输送系统的 EUS-CDS 作为二线治疗方法。评估了临床成功率、技术成功率、无需瘘管扩张的技术成功率、不良事件和支架功能障碍的发生率。
在 20 例患者中，技术成功率和临床成功率分别为 95.0%（19/20）和 100%（19/19）。在 31.6%（6/19）的患者中，输送系统无需瘘管扩张装置即可成功插入胆管。这些患者的手术时间明显短于需要瘘管扩张的患者（12.7 ± 3.1 分钟 vs 23.2 ± 2.1 分钟；P < 0.01）。1 例（5.0%）需要瘘管扩张的患者发生不良事件，经保守治疗后得到控制。无与操作相关的死亡病例。在随访期间，有 4 例（21.1%）患者发生支架功能障碍。所有病例均通过再次介入成功治疗。
EUS-CDS 方法的技术成功率为 95%，临床成功率为 100%，不良事件发生率为 5%。如果努力避免扩张步骤，EUS-CDS 可能会更安全（UMIN 000023938）。
