OBJECTIVES The study aimed to develop international consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications. METHODS Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections (PFC), biliary drainage (EUS-BD), gallbladder drainage (EUS-GBD), gastroenterostomy (EUS-GE) and gastric access temporary for endoscopy (GATE). The evidence level of each statement was determined using the GRADE methodology.International LAMS experts were invited to participate in a modified Delphi process. When no 80% consensus was reached, the statement was modified based on expert feedback. Statements were rejected if no consensus was reached after the third Delphi round. RESULTS Fifty-six (93.3%) out of 60 formulated statements were accepted, of which 35 (58.3%) in the first round.Consensus was reached on the optimal learning path, preprocedural imaging, the need for airway protection and essential safety measures during the procedure, such as the use of Doppler and measurement of the distance between the gastrointestinal lumen and the target structure.Specific consensus recommendations were generated for the different LAMS indications, covering, among others, careful patient selection, the preferred size of the LAMS, the need for antibiotics, the preferred anatomic location of the LAMS, the need for coaxial pigtail placement, and the appropriate management of LAMS-related adverse events. CONCLUSIONS Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.

中文翻译：

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使用改进的德尔福流程安全使用 LAMS 治疗标签内和标签外适应症的国际共识建议。

目的 该研究旨在针对标签内和标签外适应症安全使用内腔金属支架 (LAMS) 制定国际共识建议。方法 根据现有文献，制定陈述并将其分为以下几类：一般安全措施、胰周积液 (PFC)、胆汁引流 (EUS-BD)、胆囊引流 (EUS-GBD)、胃肠造口术 (EUS-GE)和用于内窥镜检查的临时胃通道 (GATE)。每个陈述的证据级别均使用 GRADE 方法确定。国际 LAMS 专家受邀参与修改后的德尔菲流程。当未达成80%共识时，根据专家反馈修改了声明。如果德尔福第三轮后未达成共识，声明将被拒绝。结果 60 份陈述中有 56 份（93.3%）被接受，其中第一轮 35 份（58.3%）。就最佳学习路径、术前成像、术中气道保护的必要性和基本安全措施达成共识。程序，例如使用多普勒和测量胃肠道腔与目标结构之间的距离。针对不同的 LAMS 适应症生成了具体的共识建议，其中包括仔细的患者选择、LAMS 的首选尺寸、抗生素的需要、LAMS 的首选解剖位置、同轴尾纤放置的需要以及 LAMS 相关不良事件的适当管理。结论 通过修改后的国际德尔菲流程，我们针对 LAMS 的安全使用提出了一般性和针对特定适应症的基于经验和证据的建议。