背景:该研究旨在就安全使用管腔贴壁金属支架(LAMSs)进行标签内外适应症的国际共识建议。
方法:根据现有文献,声明被制定并分为以下类别:一般安全措施,胰周积液,内镜超声(EUS)-胆道引流,EUS-胆囊引流,EUS-胃肠造口术,和胃镜检查的临时通道。每个陈述的证据水平是使用建议等级评估确定的,发展,和评价方法。国际LAMS专家应邀参加了修改后的Delphi流程。当没有达成80%的共识时,该声明是根据专家反馈修改的。如果在第三轮德尔福回合之后没有达成共识,则声明被拒绝。
结果:60份陈述中的56份(93.3%)被接受,其中第一轮35人(58.3%)。在最佳学习路径上达成共识,术前成像,在手术过程中需要气道保护和必要的安全措施,比如多普勒的使用,和测量胃肠腔和目标结构之间的距离。针对不同的LAMS适应症提出了具体的共识建议,覆盖,其中,精心挑选病人,LAMS的首选尺寸,需要抗生素,LAMS的首选解剖位置,需要同轴尾纤放置,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,我们提出了关于LAMS安全使用的一般和适应症特异性经验和循证建议.
The study aimed to develop international
consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications.
Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections, endoscopic ultrasound (EUS)-biliary drainage, EUS-gallbladder drainage, EUS-gastroenterostomy, and gastric access temporary for endoscopy. The evidence level of each statement was determined using the Grading of Recommendations Assessment, Development, and Evaluation 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.
Fifty-six (93.3%) 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.
Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.