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一种新的 20mm 腔内径贴合金属支架(lams)用于内镜治疗胰腺和胰周液体积聚的安全性和有效性:一项大型国际多中心研究。

The safety and efficacy of a new 20-mm lumen apposing metal stent (lams) for the endoscopic treatment of pancreatic and peripancreatic fluid collections: a large international, multicenter study.

机构信息

Digestive Endoscopy Unit, Humanitas Clinical and Research Center - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy.

Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals, AUSL Romagna, Forlì-Cesena, Italy.

出版信息

Surg Endosc. 2021 Apr;35(4):1741-1748. doi: 10.1007/s00464-020-07567-8. Epub 2020 Apr 22.

DOI:
10.1007/s00464-020-07567-8
PMID:32323015
Abstract

BACKGROUND

Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date.

METHODS

This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events.

RESULTS

A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction.

CONCLUSIONS

This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.

摘要

背景

腔内置入金属支架(LAMS)允许方便地进入胰周液体积聚(PPFC)并有可能进行直接内镜下坏死组织清除术(DEN)。我们的研究目的是评估新型 20mm LAMS 在 PPFC 治疗中的安全性和有效性。这种新型支架是目前市场上可用的最大直径 LAMS。

方法

这是一项国际多中心回顾性研究,涉及 20 个中心。连续接受 EUS 引导的 20mm LAMS 引流 PPFC 的患者纳入研究。主要结局为技术和临床成功率。次要结局为不良事件的发生率和严重程度。

结果

共有 105 例患者接受了新的 20mm LAMS 引流 PPFC,共放置了 106 个支架。技术成功率为 100%(106/106)。7/105 例患者因与支架无关的原因死亡。98 例患者中有 92 例(93.9%)达到临床成功。98 例患者中有 8 例(8.16%)发生了显著不良事件:4 例(4.08%)出血,3 例(3.06%)继发感染,1 例胃出口梗阻。

结论

这项多中心研究表明,对于包括胰腺包裹性坏死(WOPN)在内的 PPFC,使用新型 20mm LAMS 可获得可接受的技术和临床成功率。我们的研究结果表明,与较小直径的 LAMS 相比,新型 20mm LAMS 在管理 PPFC 包括胰腺假性囊肿(PP)和 WOPN 时,在安全性、疗效和不良事件方面无差异。需要进行随机对照研究来确定 LAMS 的理想尺寸,以在为这一高风险患者群体最大限度地降低风险的情况下获得最大的临床获益。

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