BACKGROUND AND AIMS High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients. METHODS This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs. RESULTS Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034). CONCLUSIONS Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT03544008.).

中文翻译：

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国际多中心综合分析与放置腔的金属支架置入胰液收集引流相关的不良事件。

背景和目的报道了用于腔内金属收集（PFC）引流的腔内金属支架（LAMS）放置的技术和临床成功率很高。但是，关于不良事件（AE）发生率的数据是异类的。这项研究的目的是评估大量人群中与使用LAMS引流PFC相关的AE的发生率，严重性，管理和风险因素。方法这是来自15个接受LAMS放置以管理PFC的患者的15个中心的多中心，国际回顾性研究。巢式病例对照研究是在有（病例）或没有（对照）AEs的患者中进行的。结果在328例患者中进行了333例手术（其中5例患者接受了2例LAMS治疗）。321例患者（97.9％）取得了技术成功。最终有344名患者被纳入研究（其中7名因遗失随访信息而被排除； 10名因与LAMS不相关的死亡而被排除）。临床成功率为89.5％。304例患者中有74例发生了79例LAMS相关AE（24.3％），平均时间为25.3天（中位数为18天；四分位间距为6-30），分类为轻度20例（占25.3％），54例（占68.4％） ％）中度，或5（6.3％）重度。与对照组相比，在多变量分析中，与胰腺假性囊肿相比，病例更有可能发生壁坏死（WON）（优势比，2.18； 95％置信区间，1.09-4.46； P = .028），而病例的可能性较小。经历了导管（气球）扩张（是与否；比值比，.47； 95％置信区间，.22-.93； P = .034）。结论这项来自大型国际回顾性研究的数据证实，将LAMS用于PFC的管理具有出色的技术和良好的临床成功率。但是，AEs的发生率不可忽略，在使用这些支架引流PFC尤其是WON之前，应仔细考虑。需要进一步的前瞻性研究来证实这些发现。（临床试验注册号：NCT03544008。）。