A novel lumen-apposing metal stent for EUS-guided drainage of pancreatic fluid collections: A multicenter prospective study.

IF 4.7 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Endoscopic Ultrasound Pub Date : 2026-03-01 Epub Date: 2026-05-28 DOI:10.1097/eus.0000000000000162

Huiyun Zhu, Yuting Liu, Kaixuan Wang, Danqi Zhao, Xun Li, Xiaoping Zou, Xiaofeng Zhang, Youxiang Chen, Ning Zhong, Jianying Bai, Liang Zhong, Peng Li, Bin Xiao, Wei Chen, Enqiang Linghu, Zhaoshen Li, Ningli Chai, Yiqi Du, Zhendong Jin

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引用次数: 0

Abstract

Background and objectives: Various lumen-apposing metal stents (LAMSs) were used for pancreatic fluid collection (PFC) drainage for many years. The structural design of LAMS needs to be improved to reduce the occurrence of adverse events. This trial assessed the efficacy and safety of a novel modified LAMS for the drainage of PFCs.

Methods: This open-label, multicenter, prospective trial was done at 11 tertiary care hospitals. This study enrolled patients (18-75 years old) with confirmed diagnosis of PFC with cyst diameter no less than 6 cm. Novel LAMS (Micro-Tech Co, Ltd, Nanjing, China) was used. The primary end point was the 1-month postoperative drainage success rate. The secondary end points were technical success rate and adverse events. This study is registered with Chictr.org.cn, ChiCTR2000039955.

Results: Between December 9, 2020, and December 27, 2021, 100 patients with PFC were assessed for eligibility, and 94 patients met the criteria and agreed to participate in the trial. The median size of PFC cyst was 11.23 ± 3.84 cm. The drainage success rate was 90.48% (95% CI, 83.6%-97.3%) and achieved the prespecified target value of 75% (P < 0.0001). In subgroup analysis, the clinical success rates of pancreatic pseudocyst (PPC) and walled-off necrosis (WON) were 95.45% and 85%, respectively (P = 0.143). The overall technical success rate was 98.94%. Postoperative early adverse events occurred in 57 (60.64%) of 94 patients, and late adverse events were encountered in 16 (17.02%) of 94 patients. The overall rate of serious adverse event (bleeding-related death) was 2.13% (2/94). Patients with WON had a significantly higher rate of early adverse events compared to those with PPC (77.78% vs. 44.90%, P = 0.001).

Conclusions: The novel LAMS used in this trial was technically feasible, efficient, and safe for the treatment of PFCs. Comparable with WON, the usage of LAMS in PPC achieved a high drainage success rate and acceptable adverse events.

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一种新型置管金属支架用于eus引导下的胰腺积液引流：一项多中心前瞻性研究。

背景和目的：各种腔位金属支架（LAMSs）用于胰液收集（PFC）引流已多年。lam的结构设计有待改进，以减少不良事件的发生。本试验评估了一种新型改良LAMS用于pfc引流的有效性和安全性。方法：这项开放标签、多中心、前瞻性试验在11家三级医院进行。本研究纳入的患者年龄为18-75岁，确诊为囊肿直径不小于6cm的PFC。采用Novel LAMS （Micro-Tech Co . Ltd, Nanjing, China）。主要终点为术后1个月引流成功率。次要终点为技术成功率和不良事件。本研究注册号：Chictr.org.cn, ChiCTR2000039955。结果：在2020年12月9日至2021年12月27日期间，对100名PFC患者进行了资格评估，94名患者符合标准并同意参加试验。PFC囊肿的中位尺寸为11.23±3.84 cm。引流成功率为90.48% (95% CI, 83.6% ~ 97.3%)，达到预定目标值75% （P < 0.0001）。亚组分析中，胰腺假性囊肿（PPC）和壁性坏死（WON）的临床成功率分别为95.45%和85% （P = 0.143）。总技术成功率为98.94%。94例患者中出现早期不良事件57例（60.64%），晚期不良事件16例（17.02%）。严重不良事件（出血相关死亡）的总发生率为2.13%（2/94）。WON患者的早期不良事件发生率明显高于PPC患者（77.78% vs. 44.90%, P = 0.001）。结论：本试验中使用的新型LAMS在技术上可行、有效、安全。与WON相比，在PPC中使用LAMS获得了较高的引流成功率和可接受的不良事件。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Endoscopic Ultrasound GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

6.20

自引率

11.10%

发文量

144

期刊介绍： Endoscopic Ultrasound, a publication of Euro-EUS Scientific Committee, Asia-Pacific EUS Task Force and Latin American Chapter of EUS, is a peer-reviewed online journal with Quarterly print on demand compilation of issues published. The journal’s full text is available online at http://www.eusjournal.com. The journal allows free access (Open Access) to its contents and permits authors to self-archive final accepted version of the articles on any OAI-compliant institutional / subject-based repository. The journal does not charge for submission, processing or publication of manuscripts and even for color reproduction of photographs.