Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong.
Division of Gastroenterology, Department of Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Dig Endosc. 2021 Nov;33(7):1139-1145. doi: 10.1111/den.13911. Epub 2021 Jan 11.
Long-term placement of lumen apposing metal stents (LAMS) with high lumen apposing force may result in adverse events. The aim of the current study was to assess the long-term efficacy and safety of a self-approximating LAMS with lower lumen apposing force for endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) and -gallbladder drainage (EUS-GBD).
Five Asian institutions participated in this study. Consecutive patients suffering from obstructive jaundice with failed ERCP or acute cholecystitis that were at high risk for cholecystectomy were recruited. We evaluated the technical and clinical success rates, adverse events rates, types of interventions through the stent and the patency profile.
From June 2017 to Oct 2018, a total of 53 patients received EUS-CDS (26) and EUS-GBD (27). The technical and clinical success rates were similar between the two groups (88.5% vs 88.9%, P = 1 and 88.5% vs 88.9%, P = 1 respectively). The differences in 30-day mortality rates [2 (7.7%) vs 2 (7.7%), P = 1] and adverse events [3 (11.5%) vs 3 (11.5%), P = 1] did not reach significance. Regarding long-term outcomes, two patients in each group suffered from adverse events (P = 1). One patient in the EUS-GBD group who was on direct oral anticoagulant suffered from stent induced bleeding.
The self-approximating LAMS with lower lumen apposing force was effective and safe with a low risk of buried stent syndrome and bleeding in the longer term. The ClinicalTrials.gov Identifier was NCT03002051.
长期放置具有较高管腔贴合力的腔镜贴合金属支架（LAMS）可能会导致不良事件。本研究旨在评估具有较低管腔贴合力的自贴合 LAMS 在超声内镜引导下胆肠吻合术（EUS-CDS）和胆囊引流术（EUS-GBD）中的长期疗效和安全性。
五家亚洲机构参与了这项研究。连续入组因 ERCP 失败或急性胆囊炎而患有梗阻性黄疸且胆囊切除术风险较高的患者。我们评估了技术和临床成功率、不良事件发生率、通过支架进行干预的类型以及通畅情况。
2017 年 6 月至 2018 年 10 月，共有 53 例患者接受了 EUS-CDS（26 例）和 EUS-GBD（27 例）。两组之间的技术和临床成功率相似（88.5% vs 88.9%，P=1 和 88.5% vs 88.9%，P=1）。30 天死亡率[2（7.7%）vs 2（7.7%），P=1]和不良事件[3（11.5%）vs 3（11.5%），P=1]的差异无统计学意义。关于长期结果，每组有 2 例患者发生不良事件（P=1）。EUS-GBD 组中有 1 例正在服用直接口服抗凝剂的患者发生支架诱导出血。
具有较低管腔贴合力的自贴合 LAMS 在长期内有效且安全，发生埋藏支架综合征和出血的风险较低。临床试验注册号为 NCT03002051。
