Biflanged metal stents versus plastic stents for endoscopic ultrasound-guided drainage of walled-off necrosis: a randomized controlled trial.

IF 11.5 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Endoscopy Pub Date : 2024-12-01 Epub Date: 2024-05-23 DOI:10.1055/a-2332-3448
Krithi Krishna Koduri, Nitin Jagtap, Sundeep Lakhtakia, Basha Jahangeer, Shujaath Asif, Rupjyoti Talukdar, Guru Trikudanathan, Manu Tandan, Rakesh Kalapala, Zaheer Nabi, Rajesh Gupta, Mohan Ramchandani, Jagadish Singh, Sana Fatima Memon, G Venkat Rao, D Nageshwar Reddy
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引用次数: 0

Abstract

Background: Endoscopic ultrasound (EUS)-guided drainage of walled-off necrosis (WON) using either plastic or metal stents is the mainstay of WON management. Our single-center randomized controlled trial aimed to evaluate the efficacy of biflanged metal stents (BFMSs) and plastic stents for WON drainage.

Methods: Patients with symptomatic WON amenable to EUS-guided drainage were randomized to receive either BFMSs or plastic stents. The primary outcome was reintervention-free clinical success at 4 weeks. Secondary outcomes were: overall clinical success (complete resolution of symptoms and significant reduction in size of WON [<50% of original size and <5 cm in largest diameter at 4-week follow-up]); number of reinterventions; adverse events (AEs); hospital stay for first admission; and medium-term outcomes at 6 months (recurrence, disconnected pancreatic duct, chronic pancreatitis, and new-onset diabetes mellitus).

Results: 92 patients were randomized: 46 in each arm. The reintervention-free clinical success rate was significantly higher in the BFMS group on intention-to-treat analysis (67.4% vs. 43.5%; P = 0.02). Overall clinical success at 1 month was similar in both groups. There were significantly fewer reinterventions (median 0 [IQR 0-1] vs. 1 [0-2]; P = 0.03) and shorter hospital stays in the BFMS group (7.0 [SD 3.4] vs. 9.1 [5.5] days; P = 0.04). There were no differences in procedure-related AEs, mortality, or medium-term outcomes.

Conclusions: BFMSs provide better reintervention-free clinical success at 4 weeks, with shorter hospital stay and without increased risks of AEs, compared with plastic stents for EUS-guided drainage of WON. Medium-term outcomes are however similar for both stent types.

内镜超声引导下壁脱落坏死引流术中双翼金属支架与塑料支架的对比:随机对照试验。
目的:在内镜超声(EUS)引导下使用塑料支架或金属支架引流贴壁坏死(WON)是WON治疗的主要方法。本研究是一项单中心随机对照研究,评估了双法兰金属支架(BFMS)和塑料支架用于WON引流的疗效:设计:无症状 WON 患者可在 EUS 引导下进行引流,患者随机选择 BFMS 或塑料支架。主要结果是4周后无再介入的临床成功率。次要结果是总体临床成功率(症状完全缓解和 WON 体积显著缩小):92 名患者接受了随机治疗,每组 46 人。BFMS组的无再干预临床成功率明显更高(67.4% vs 43.5%;P:0.021;ITT分析)。两组患者一个月后的总体临床成功率相似。BFMS 组的再干预次数(中位数 0(IQR 0-1) vs 1(0-2);P:0.028)和住院时间(7.04 ± 3.36 天 vs 9.09 ± 5.53 天;P:0.035)明显少于 BFMS 组。在手术相关不良事件、死亡率和中期预后方面没有差异:结论:与塑料支架相比,BFMS在EUS引导下引流WON时,4周内无再介入的临床成功率更高,住院时间更短,且不会增加不良事件的风险。不过,BFMS 和塑料支架的中期疗效相似。
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
Endoscopy
Endoscopy 医学-外科
CiteScore
5.80
自引率
11.80%
发文量
1401
审稿时长
2 months
期刊介绍: Endoscopy is a leading journal covering the latest technologies and global advancements in gastrointestinal endoscopy. With guidance from an international editorial board, it delivers high-quality content catering to the needs of endoscopists, surgeons, clinicians, and researchers worldwide. Publishing 12 issues each year, Endoscopy offers top-quality review articles, original contributions, prospective studies, surveys of diagnostic and therapeutic advances, and comprehensive coverage of key national and international meetings. Additionally, articles often include supplementary online video content.
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